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    Recommendation 1 

    A course of non-operative treatment is an option in patients diagnosed with carpal tunnel syndrome. Early surgery is an option when there is clinical evidence of median nerve denervation or the patient elects to proceed directly to surgical treatment.

    (Grade C, Level V) 

    Rationale

    Data were extracted from three systematic reviews and twenty-three randomized controlled or controlled trials for evidence to support this recommendation. The literature found supported the effectiveness of non-operative treatment over placebo. Data were not found that clearly identified when non-operative treatment should be considered the only option, nor were studies found in which non-operative treatment was clearly shown to be completely ineffective and therefore contraindicated.
     
    Studies of carpal tunnel syndrome often included denervation as an indication for surgery, and a relative contraindication for non-surgical treatment, so such cases were not studied systematically. Consequently, it was not possible to make a Grade A or B recommendation.
    Therefore, this guideline recommendation is, of necessity, based upon expert opinion.

    See Evidence Tables 1-21 and Evidence Report (PDF Page 12)

     

    Recommendation 2

    We suggest another non-operative treatment or surgery when the current treatment fails to resolve the symptoms within 2 weeks to 7 weeks.

    (Grade B, Level I and II)

    Rationale

    Considerable evidence exists that suggets patients benefit from a variety of non-operative treatment and surgical options for carpal tunnel syndrome. Although the date did not report the minimum time for effectiveness, an analysis of the level I and II data reviewed for Recommendations 4a-c suggested that all effective or potentially effective non-operative treatments (local steroid injections, splinting, oral steroids and ultrasound) for carpal tunnel syndrome have a measureable effect on symptoms within two to seven weeks of the initiantion of treatment. If a treatment is not effective in reducing symptoms within that time frame, then consideration should be given to trying a different one, assuming, of course, that the diagnosis of carpal tunnel syndrome is not in doubt.

    Because this recommendation considers a variety of non-operative treatments, the levels of evidence varied. More level II evidence exists than level I evidence; hence the grade of recommendation is based on consistent level II evidence.
     
    See Evidence Tables 1-21 and Evidence Report (PDF Page 13)
     

    Recommendation 3 

    We do not have sufficient evidence to provide specific treatment recommendations for carpal tunnel syndrome when found in association with the following conditions: diabetes mellitus, coexistent cervical radiculopathy, hypothyroidism, polyneuropathy, pregnancy, rheumatoid arthritis, and carpal tunnel syndrome in the workplace.

    (Inconclusive, No evidence found) 

    Rationale

    Despite an exhaustive review of the literature, there was insufficient evidence to make conclusions about these conditions and carpal tunnel syndrome in the workplace. These potentially treatable medical conditions are common exclusion criteria from controlled trials. This makes it difficult to make specific recommendations for how to treat such patients.

    See Evidence Tables 1-21 and Evidence Report (PDF Pages 12-15)

     

    Recommendation 4A

    Local steroid injection or splinting is suggested when treating patients with carpal tunnel syndrome, before considering surgery.

    (Grade B, Level I and II) 

    Rationale

    Local steroid injection and splinting are effective in treating carpal tunnel syndrome. Splinting was effective at 2, 4, and 12 weeks in reducing symptoms and improving functional status. No conclusion could be drawn at the 6 month time point because the studies were underpowered.

    Steroid injections are also effective for treating carpal tunnel syndrome. Patient satisfaction (2 weeks 23), clinical improvement (4 weeks44, 77 8 weeks,116 12 weeks 116), symptoms (2 weeks,58 4 months,27 6 months 108), function (3 months 108), and pain (8 weeks 58) were shown to improve after cortisone injections.

    Patients with more severe or prolonged CTS, however defined, may not benefit from prolonged, non-operative treatment. Trials of non-operative treatment are suggested for the treating physician and should show remission as described in the recommendations above at the intervals indicated.
     
    See Evidence Tables 1- 21 and Evidence Report (PDF Pages 16-61, Figures 1-6, & 37-41)
     
     

    Recommendation 4B 

    Oral steroids or ultrasound are options when treating patients with carpal tunnel syndrome.

    (Grade C, Level II)

    Rationale

    Oral steroid treatment was effective in the treatment of carpal tunnel syndrome. However, the evidence suggested that local steroid injection is more effective than oral steroids. Since the evidence supports other more effective treatments, the Work Group downgraded the recommendation about oral steroids to Grade C, “optional”.
     
    Ultrasound was also shown to be effective in the treatment of carpal tunnel syndrome in two studies. One of the studies 28 however, compared ultrasound to laser treatment, an unproven modality, rather than to a control. Hence, there was only one level II study supporting ultrasound. Based on this methodological flaw, the Work Group chose to downgrade this recommendation on ultrasound to Grade C, “optional”.
     
    See Evidence Tables 1- 21 and Evidence Report (PDF Pages 16-61, figures 12-15, 23, & 24)
     
     

    Recommendation 4C 

    We recommend carpal tunnel release as treatment for carpal tunnel syndrome.

    (Grade A, Level I)

    Rationale

    Level I evidence demonstrates that surgical release of the flexor retinaculum is an extremely effective treatment for patients with carpal tunnel syndrome. The evaluation of operative versus non-operative treatment of carpal tunnel syndrome demonstrated the effectiveness of the surgical treatment.
     
    These recommendations assume that the patient has reversible mechanical compression of the median nerve based on the diagnostic criteria set forth in the AAOS clinical practice guideline for The Diagnosis of Carpal Tunnel Syndrome. This does not include patients who have nerve damage characterized by irreversible microscopic damage to the nerve ultra-structure. Such cases, understood to exist, without biopsy evidence, have a worse prognosis for recovery with sustained numbness, tingling, paralysis, dyshidrotic changes of the skin, and pain. Diagnostic stratification studies which define preoperative criteria for this division between reversible and irreversible damage were not found. The clinical objective in the more damaged group has lesser expectations and anticipated outcomes by definition.
     
    See Evidence Tables 1-21 and Evidence Report (PDF Pages 62-66, Figures 53-58)
     
     

    Recommendation 4D

    Heat therapy is not among the options that should be used to treat patients with carpal tunnel syndrome.

    (Grade C, Level II) 

    Rationale 

    Heat therapy was less effective than placebo control in treating carpal tunnel syndrome. The grade of recommendation is based on a single study therefore, it was downgraded to Grade C, “optional”.
     
    See Evidence Tables 1- 21 and Evidence Report (PDF Page 43, Figure 30)
     

    Recommendation 4E

    The following treatments carry no recommendation for or against their use: activity modifications, acupuncture, cognitive behavioral therapy, cold laser, diuretics, exercise, electric stimulation, fitness, graston instrument, iontophoresis, laser, stretching, massage therapy, magnet therapy, manipulation, medications (including anticonvulsants, antidepressants and NSAIDs), nutritional supplements, phonophoresis, smoking cessation, systemic steroid injection, therapeutic touch, vitamin B6 (pyridoxine), weight reduction, yoga.

    (Inconclusive, Level II and V)

    Rationale 

    Despite an extensive review of the literature, there was insufficient evidence to make conclusions about these modalities. For some treatments, there were simply no studies that met the inclusion criteria. For others, the studies had too little statistical power to allow for meaningful conclusions. Still other studies were downgraded from a higher grade of recommendation because their applicability was questioned. Consequently, we are unable to make recommendations for or against the use of these treatments.
     
    One study compared the Graston Instrument to manual therapy. The applicability of this study was questioned because the Graston instrument was compared to an unproven alternative treatment. This was the only study looking at the Graston instrument that met the inclusion criteria. The grade of recommendation was downgraded because the evidence was inconclusive. 
     
    One systematic review examined the comparison of Vitamin B (pyridoxine) to placebo. The applicability of the outcome measure was questioned because it was not considered to be critical to determining whether Vitamin B was beneficial in the treatment of CTS. The grade of recommendation was downgraded because the evidence was inconclusive.
     
    All of these modalities require further investigation in appropriately designed studies to determine their efficacy in the treatment of carpal tunnel syndrome.
     
    See Evidence Tables 1- 21 and Evidence Report (PDF Pages 16-61)
     
     

    Recommendation 5

    We recommend surgical treatment of carpal tunnel syndrome by complete division of the flexor retinaculum regardless of the specific surgical technique. 

    (Grade A, Level I and II)

    Rationale

    Complete division of the flexor retinaculum is an effective method for treating CTS. Two systematic reviews and six randomized controlled trials examined comparisons between open carpal tunnel release, endoscopic carpal tunnel release, or minimal incision carpal tunnel release. Several patient-oriented outcome measures, including symptom severity and functional status at 52  post-operatively, residual pain at 12 weeks post-operatively, reversible nerve damage, return to work and wound-related complications, were evaluated using meta analytic techniques to compare open release and endoscopic release. Endoscopic release was favored in residual pain at 12 weeks post-operatively, return to work time, and wound related complications. Open release was favored when reversible nerve damage was the outcome compared. No difference in the techniques was found in symptom severity or functional status at 52 weeks, complications, and infections. 
     
    In addition, minimal incision release was compared to open or endoscopic release in Level I studies. When compared to open release, minimal incision was favored in symptom severity, functional status, and scar tenderness. When compared to endoscopic release, minimal incision was favored when pain at two or four weeks was the outcome measure. 
     
    The Work Group discussed the studies and agreed that not all relevant outcomes were available, addressed, and/or analyzed by the evidence comparing the various surgical techniques. Nevertheless, Level I and Level II evidence clearly indicates the effectiveness of complete division of the flexor retinaculum, regardless of surgical technique, as a treatment for CTS.
     
    See Evidence Tables 23-37 and Evidence Report (PDF Pages 68-87, Figures 59-81)
     
     

    Recommendation 6

    We suggest that surgeons not routinely use the following procedures when performing carpal tunnel release:

    Skin nerve preservation (Grade B, Level I) 

    Epineurotomy (Grade C, Level II) 

    The following procedures carry no recommendation for or against their use: flexor retinaculum lengthening, internal neurolysis, tenosynovectomy, ulnar bursa preservation.

    (Inconclusive, Level II and V)

    Rationale

    A single Level I study evaluated the effect of preserving cutaneous nerves in the path of a skin incision made in the customary location for a carpal tunnel release. Preservation was compared to a standard approach to making a skin incision, which did not seek to preserve any nerve branches encountered as the wound was deepened down to the palmar fascia. The Patient Evaluation Measure (PEM) indicated a slight advantage in favor of the standard approach at the three-month assessment. The PEM is a broader evaluation of outcome than the VAS suggesting that the advantages for a standard carpal tunnel release incision refer to a domain other than pain.
     
    Epineurotomy was studied in a systematic review and in a single Level II study. In the systematic review 97 the outcome was described as “overall improvement” at 12 months and, in the single Level II study, 34 the outcomes were “nocturnal pain” and “paraesthesia” at three months following surgery. Both studies indicated a mild effect favoring no epineurotomy. 

    Tenosynovectomy and internal neurolysis were compared in a systematic review 97 and the data were inconclusive. Lengthening of the flexor retinaculum was studied in a Level I study 49 that used the Boston Carpal Tunnel Questionnaire as the outcome measure. The results were inconclusive because the study had too little power to allow for statistically meaningful comparison. A single Level I study 53 examining ulnar bursa preservation, with VAS and PEM as the outcome measures at 8 weeks, also had too little power to allow for meaningful statistical comparisons. The study was therefore inconclusive.

    See Evidence Tables 23-37 and Evidence Report (PDF Pages 88-95, Figures 82-88)

     

    Recommendation 7

    The physician has the option of prescribing pre-operative antibiotics for carpal tunnel surgery. 

    (Grade C, Level III) 

    Rationale 

    Our searches indicated that the current literature rarely reports whether pre-operative antibiotic treatment was used in carpal tunnel release. Of forty-five studies analyzed for this recommendation, forty-four did not report whether pre-operative antibiotics were used. The study that did report antibiotic use reported that 6.03% of patients developed a post-operative infection, even though all patients received antibiotics.

    An examination of the various trials addressing carpal tunnel syndrome treatment did not provide insight on whether there are conditions or comorbidities that predispose patients to post-surgical infection. Patients with diabetes mellitus, for example, were excluded from the trials. A single Level IV study looked at rates of post-operative infections in persons with and without diabetes and found that the rate was similar in the two groups.

    See Evidence Tables 38-41 and Evidence Report pages 96-100.

     

    Recommendation 8

    We suggest that the wrist not be immobilized postoperatively after routine carpal 
    tunnel surgery.

    (Grade B, Level II) 

    We make no recommendation for or against the use of postoperative rehabilitation.

    (Inconclusive, Level II)

    Rationale

    The wrist should not be immobilized postoperatively after routine carpal tunnel release. Post-operative splinting for longer than two weeks did not offer any specific benefit in terms of grip or lateral pinch strength, bowstringing, complication rates, subjective outcome and patient satisfaction.

    Clinicians may wish to provide protection for the wrist in a working environment or for temporary protection. However, the evidence does not provide objective criteria for these situations. Clinicians should be aware of the detrimental affects including adhesion formation, stiffness and prevention of nerve and tendon movement which may compromise the carpal tunnel release results in achieving another objective such as early release to work.

    For postoperative rehabilitation, one study examined supervised hand therapy. The applicability of the outcome measure (return to work) was questioned because it was not considered to be critical to determining whether supervised hand therapy was beneficial to postoperative rehabilitation. The grade of recommendation was downgraded because the evidence was inconclusive.

    There were no included studies that looked at work hardening and the role of various modalities for post-operative carpal tunnel management. The role of supervised therapy after carpal tunnel release in the work-related population will need further evaluation to determine if there is any advantage to work hardening, work simulation, or routine strengthening.

    See Evidence Tables 42-51 and Evidence Report (PDF Pages 101-110, Figures 92-101)

     

    Recommendation 9

    We suggest physicians use one or more of the following instruments when assessing patients’ responses to CTS treatment for research: 

    Boston Carpal Tunnel Questionnaire (disease-specific) 
     
    DASH – Disabilities of the arm, shoulder, and hand (region-specific; upper limb) 
     
    MHQ – Michigan Hand Outcomes Questionnaire (region-specific; hand/wrist) 
     
    PEM (region-specific; hand) 
     
    SF-12 or SF-36 Short Form Health Survey (generic; physical health component for global health impact) 

    (Grade B, Level I, II, and III) 

    Rationale 

    All measurement instruments, whether they are aimed at diagnosis, evaluation of disease activity or outcome, must be judged on their key psychometric characteristics: reliability, validity, interpretability and responsiveness. Reliability was generally measured in these studies by assessing the internal consistency and reproducibility of the study.

    Per Jenkinson 67, “validity is assessed in relation to a specific purpose and setting.” Validity is established statistically for an instrument by measuring construct validity, convergent and divergent validity, and/or criterion validity. Instruments having construct validity are summarized in the table below.

    Convergent and divergent validity measures can be found in the Evidence Tables (Tables 69-85). More information concerning interpretation of these measures can be found in the Evidence Report but an inclusive discussion is beyond the scope of the guideline. These values were not graphed and were provided to illustrate the direction and magnitude of relationships. Criterion validity was not summarized.

    While adequate reliability and validity are concepts that are, for the most part, clear to clinicians, the capacity for interpretability and responsiveness may be less familiar. Interpretability refers to the fundamental meaning of the measure. Instruments that encompass items that are meaningful to patients and/or clinicians will have good interpretability and users can easily understand the meaning of these measures. Few studies measured interpretability therefore they are not summarized in the table below.

    Responsive measures reflect small changes in a given condition. This may be important where subtle differences could be clinically important. Responsive measures are helpful in the planning of trials where the objective may be to demonstrate a small difference between, for example, treatments. 

    Generally speaking, generic measures, like the Short Form 36 (SF-36), look at a broadly based assessment of health and, as a result may not be very responsive to changes in status related to a relatively minor condition such as CTS.

    Disease-specific instruments such as the Boston Carpal Tunnel Questionnaire (BCTQ) are most responsive.The BCTQ shows excellent responsiveness for the measurement of disease activity in CTS. Wherever possible the full instrument should be used because this gives the most comprehensive evaluation of both function and symptoms in CTS without any loss of responsiveness. The subscales of this instrument also have satisfactory responsiveness but give a more narrow view of disease activity. The BCTQ is fully validated in the treatment of carpal tunnel syndrome.

    The region-specific instrument, The Disabilities of the Arm, Shoulder and Hand (DASH) was moderate to highly responsive and the Michigan Hand Outcomes Questionnaire (MHQ) was highly responsive in three of five subscales.

    The Patient Evaluation Measure (PEM), (MHQ) and DASH are more broadly based region-specific instruments that can be considered to be responsive for the evaluation of CTS. The responsiveness of the DASH is slightly below the acceptable threshold (standardized response mean (SRM) = 0.80) but should be considered if the goal of the evaluation is a focus on disability because it has been evaluated in three key domains: internal consistency, reproducibility and responsiveness.

    See Evidence Tables 52-101 and Evidence Report (PDF Pages 111-125, Figures 102-120)

     

    Future Research 

    Although we make every effort to find studies of the highest quality, such evidence is not readily available for carpal tunnel syndrome treatment at this time. This guideline has been hindered by a relative lack of power in the studies even though these studies were of Level I and II evidence. The recommendations of this guideline therefore depend to some degree on lesser evidence, including expert opinion.

    To achieve a high-quality literature base, academic authors and scientists should invest their time and effort in studies designed to avoid bias (e.g., blinded and properly randomized controlled trials of sufficient power to address the outcome of interest). Future studies should, from the onset, be based on improved study design that includes a priori power calculations. Risk stratification studies are also needed to detect when antibiotics might be justified on the basis of co-morbidities and co-interventions.
     
    We recognize that the issue of carpal tunnel syndrome in the workplace is important. Studies identified by the literature search commonly analyze risk, prevalence, and predictability of carpal tunnel syndrome in specific job categories but good evidence to address the effectiveness of workplace modifications was not available. Working patients, payors, and physicians clearly lack the evidence base to determine “best options”. Physicians and patients must first decide the desired outcome. Should the goal be permanent modification of activities for the worker or proceed to surgery and return to normal activities? Future research must rigorously address this subpopulation to determine if activity modification will result in positive outcomes such as ultimately avoiding surgery.

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