NCT06229249

Brief Summary

Carpal tunnel syndrome (CTS), also known as median mononeuropathy, occurs when the median nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist. It is common in the age group of 40-60 years. The main aim of the study was to compare the effectiveness of carpal ligament self-myofascial stretching over conventional physical therapy on reducing pain and improving function in patients with stage I and II CTS-thirty-six subjects with stage I and II (mild) CTS were recruited. Thirty-six subjects who fulfilled the inclusion criteria were randomly assigned to the experimental group and control group, with 18 patients in each group. The experimental group received carpal ligament self-myofascial stretching along with conventional physical therapy, while the control group received traditional physical therapy alone. The duration of the treatment was six weeks. The outcome measures used were the Boston Carpal Tunnel Questionnaire and the Visual Analogue Scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 19, 2024

Last Update Submit

January 19, 2024

Conditions

Keywords

Myo-fascial stretchingPainFunction

Outcome Measures

Primary Outcomes (2)

  • Boston Carpal Tunnel Questionnaire

    The Boston carpal tunnel syndrome is a disease-specific patient-filled questionnaire, which comprises of two scales, a symptom severity scale (SSS) and a functional status scale (FSS). The symptom severity scale has 11 questions scored from 1 point (mildest) to 5 points (most severe) and the functional status scale has eight questions scored from 1 point (no difficulty with activity) to 5 points (cannot perform the activity at all). The greater the score, the more severe the severity of the disease.

    6 weeks

  • Visual Analogue Scale

    The visual analogue scale consists of a 10-cm line, with the left extremity representing (the absence of pain) and the right extremity indicating (great pain). The greater the score, the more severe will be the pain.

    6 weeks.

Study Arms (2)

Experimental group

EXPERIMENTAL

The participants in this group received carpal ligament self-myofascial stretching along with conventional physical therapy.

Other: Carpal ligament self-myofascial stretching

Control group

ACTIVE COMPARATOR

The participants in this group received conventional physical therapy.

Other: Conventional physical therapy

Interventions

Carpal ligament self-myofascial stretching is a technique that involves applying pressure and stretching to the carpal ligaments and surrounding myofascial tissues of the wrist and hand. The objective is to release tension, improve flexibility, and alleviate discomfort or pain in the wrist and hand area.

Experimental group

In this technique, ultrasound therapy, nerve gliding exercise, tendon gliding exercise, and wrist splinting were performed.

Control group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with CTS between age group 30 - 60 years.
  • Patients with stage I and II (mild) CTS, confirmed by nerve conduction study (EMG diagnosed by a medical professional).
  • Patients who are able to read and understand English.

You may not qualify if:

  • Presence of polyneuropathy.
  • Consistent use of adaptive equipment, such as wheel chair or cane.
  • Patients presenting with shoulder pathologies.
  • Patients with other neurological or musculoskeletal conditions including Cervical radiculopathy, History of wrist and hand fractures, Upper extremity joint dislocations, Brachial plexus injuries, Cubital tunnel syndrome, Rheumatoid arthritis, De quervain's tenosynovitis, Cut injuries of hand.
  • Patients who have underwent recent carpal tunnel release (within 1 year).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromePain

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Masood Khan, MPTh

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 29, 2024

Study Start

November 17, 2022

Primary Completion

April 10, 2023

Study Completion

May 15, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations