Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome

Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome: a Randomized Clinical Trial

Hypothesis: Manipulative treatment can relieve patients of discomfort and dysfunction and then be utilized as a cheap conservative management of CTS. Study design: Two-groups randomized single-blind interventional study.

Study Overview

• Status: Unknown
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Manipulative treatment; Procedure: Simulated manipulative treatment

Detailed Description

Background: Carpal Tunnel Syndrome (CTS) is the most common compressive neuropathy in the upper limb. It considerably impairs patient's quality of life and generates important social consequences due to the lost of productivity and the cost of treatments. Both surgical and conservative treatment are utilized for CTS management. Manipulative treatment is a conservative, non-drug and cheap management option which can be proposed, but by now, treatment guidelines and reviews do not recommend it due to lack of evidence to assess his efficacy.

Hypothesis: Manipulative treatment can relieve patients of discomfort and dysfunction and then be utilized as a cheap conservative management of CTS.

Study design: Two-groups randomized single-blind interventional study. Methods: Sixty-six patients reporting CTS symptoms that are confirmed by clinical exam and nerve conduction studies will be included. Participants will be randomized in two arms, one receiving manipulative treatment and one receiving simulated manipulative treatment (1/week for 4 weeks). The main outcome measures will be the DASH questionnaire, the Boston Carpal Tunnel Syndrome Questionnaire, patient estimate on Visual Analog Scale for pain and the EuroQol-5D scale. All outcomes measures will be administrated to participants before the first manipulation, after the last session (4 weeks) and 12 weeks after the baseline measure.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Symptoms of canal tunnel syndrome (CTS) : pain, numbness, paresthesia, diminished grip strength
• Electromyography confirming CTS

Exclusion Criteria:

• Previous surgical procedure for CTS in the same wrist
• Possible secondary CTS : hypothyroidism, diabetes mellitus, pregnancy, rheumatologic diseases, neck or shoulder complaints,
• Hand and wrist pathological conditions as previous disease, intervention, traumatism, anatomic abnormalities in shape or size.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manipulative treatment; Manipulative Treatment	Procedure: Manipulative treatment; Manipulative treatment as described by the GBMOIM (Grupo Barcelona de Medicina Ortopédica y Manual) will be perform with extension of the transverse carpal ligament maneuver and fascia release maneuver
Sham Comparator: Simulated manipulative treatment	Procedure: Simulated manipulative treatment; Simulated Manipulative Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Boston Carpal Tunnel Questionnaire	self-administered questionnaire for the assessment of severity of symptoms and functional status in patients who have carpal tunnel syndrome. It has two distinct scales : a symptom-severity scale (11 - Page 2 of 3 [DRAFT] - items) and a functional-status scale (8 items). It has been validated and demonstrated to show good responsiveness and reliability in evaluating outcome after carpal tunnel release. The Spanish version has been validated	Baseline, 4 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in DASH Outcome Measure	30-item, self-report questionnaire designed to measure physical function and symptoms in people with a musculoskeletal disorder of the upper limb. It showed a large degree of responsiveness after CTS treatment and the Spanish version has been validated	Baseline, 4 weeks, 12 weeks
Change in Visual Analog Scale for pain	VAS has eleven points from 0 to 10, being 0 no pain at all, and 10 the worst pain could ever be imagined	Baseline, 4 weeks, 12 weeks
Change in EuroQol-5D scale	Quality-of-life's measure instrument which consists of a combination of a 5 items questionnaire and a Visual analogue scale. Both validity and responsiveness have been demonstrated in patients with chronic pain, and it has been evaluated in patients with CTS symptoms. The Spanish version has been validated	Baseline, 4 weeks, 12 weeks
Change in strength (Dynamometer)	Measuring pulp pinch strength with digits I and II	Baseline, 4 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Investigators: Principal Investigator: Julia Schmitt, PM&RResident, Hospital Arnau de Vilanova, Valencia, Spain; Study Director: Julio Domenech, MD-PhD, Hospital Arnau de Vilanova, Valencia, Spain

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: MOM-STC