Efficacy of Manipulative Treatment for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02611193
• Other study ID #: MOM-STC
• Status: Not yet recruiting
• Phase: N/A
• First received: July 23, 2015
• Last updated: November 18, 2015
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2015
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: Julia Schmitt
• Email: juliaschmitt81[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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
• Simulated manipulative treatment
Simulated Manipulative Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Change in strength (Dynamometer)	Measuring pulp pinch strength with digits I and II	Baseline, 4 weeks, 12 weeks	No