Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome

July 17, 2022 updated by: Hamna Syed, Dow University of Health Sciences

Effects of Soft Tissue Massage Along With Mobilization Technique on Intensity of Symptoms and Functional Status of Carpal Tunnel Syndrome - A Randomized Controlled Trial

The objective of this experimental study is to determine the effect of soft tissue massage along with mobilization technique on intensity of pain by visual analog scale and functional status by using Jamar hand-held dynamometer, Pinch Gauge and Boston Scale for carpal tunnel syndrome questionnaire in Carpal tunnel syndrome patients. It is being conducted on patients with Carpal tunnel syndrome at Sindh Institute of Physical Medicine and Rehabilitation, Karachi and Neurological outpatient department of Dr. Ruth K. M. Pfau, Civil Hospital Karachi among Sixty participants with mild and moderate severity of Carpal Tunnel Syndrome will be randomly allocated in two groups after initial screening by a consultant physiatrist according to CTS-6 scale. Written informed consent will be taken from each participant. Group A will be treated with soft tissue massage (Medenci hand massage technique) along with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique while group B will be treated with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique only. Participant will be evaluated by visual analog pain scale, Boston scale of carpal tunnel syndrome, dynamometer and -pinch gauge, Center for Epidemiologic Studies Depression Scale and Pain Anxiety Symptoms Scale on day 1 and last treatment session.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Sindh Institute of Physical Medicine and Rehabilitation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hamna Syed, DPT
        • Sub-Investigator:
          • Dr. Syed Imran Ahmed, MBBS,FCPS
        • Sub-Investigator:
          • Dr. Naila Naeem Shahbaz, MBBS,FCPS
        • Sub-Investigator:
          • Aftab Ahmed Mirza Baig, DPT,MSAPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consultant Physiatrist will be diagnosed patients of carpal tunnel syndrome on electro diagnostic test i.e. Nerve Conduction Studies.
  • Mild and moderate severity of Carpal tunnel syndrome.
  • Age: 18-50 years
  • Both gender patients with unilateral involvement of the hand

Exclusion Criteria:

  • Exclusion Criteria:

    • In electro diagnostic test, either motor or sensory deficit in the ulnar nerve and radial nerve.
    • Other Neurological problems ( cervical myelopathy, motor neuron disease like amyotrophic lateral sclerosis
    • Neoplasm around the affected arm
    • Presence of other musculoskeletal problems of upper quadrant (for example: rheumatoid arthritis or fibromyalgia, cervical radiculopathy)
    • Any recent history of trauma of upper extremity on affected side

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soft tissue mobilization + joint and nerve Mobilization

Soft tissue massage therapy includes Madenci hand massage technique initiate with 30-second (sec) effleurage, followed by 60- sec friction, 30-sec petrissage, 30-sec shaking, and ends with 30-sec effleurage. It takes totally of 3 min Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

. Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs.
Other: Soft tissue mobilization

Soft tissue massage therapy includes Madenci hand massage technique initiate with 30-second (sec) effleurage, followed by 60- sec friction, 30-sec petrissage, 30-sec shaking, and ends with 30-sec effleurage. It takes totally of 3 min Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

. Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs

Other Names:
  • Nerve mobilization( Slider technique)
  • Joint mobilization
Other: Joint and nerve mobilization

Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs.
Active Comparator: joint and nerve mobilizations

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

. Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs
Other: Joint and nerve mobilization

Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity on Visual Analog Scale in centimeter after sixth week
Time Frame: At baseline and after completion of study at after sixth week
Visual Analog Scale can be defined as a subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient in pain intensity measurement. The patients rate their pain intensity on 0 to 10 cm where 0 cm refers 'no pain' and 10 cm refers 'most excruciating pain'. Increase in number of cm suggests worst pain.
At baseline and after completion of study at after sixth week
Change in symptoms severity and functional status on scale of Boston Carpal Tunnel Questionnaire in scores
Time Frame: At baseline and after completion of study at after sixth week

It is a self-administered likert scale, containing two parts, namely the symptom severity scale and the functional status scale. It is used to assess the severity of symptoms and evaluate the difficulty in implementing the designated task. Symptom severity scale contains 11 items and the functional status scale contans 8 items. Higher the score in both scales indicating higher severity and more difficulty in performing the task.

Scoring for Symptoms severity scale:

Less than 11 or 11 = Asymptomatic, 12 to 22 = Mild, 23-33 = Moderate, 24-44 = Severe, 45-55 = Very Severe

Scoring for Functional status scale:

less than 8 or 8 = Asymptomatic, 9-16 = Mild, 17-24 = Moderate, 25-32 = Severe, 33-40 = Very Severe

The total score of both scale is calculated as the mean of the scores for the total items of scale.
At baseline and after completion of study at after sixth week
Change in hand grip strength by using Jamar dynamometer
Time Frame: At baseline and after completion of study at sixth week
Hand grip strength is quantify in kilogram by using Jamar dynamometer. Measurements was taken three times of each individuals and then calculated mean of these readings.
At baseline and after completion of study at sixth week
Change in pinch strength by using Pinch Gauge
Time Frame: At baseline and after completion of study at sixth week
Pinch grip strength is measured in kilogram by using Pinch Gauge. Measurements was taken three times of each individuals and then calculated mean of these readings.
At baseline and after completion of study at sixth week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Pain Anxiety Symptoms Scale-20
Time Frame: At baseline and after completion of study at sixth week

A 20 items scored on a 6-point scale from 0-5. This self-reported scale is used to assess fear of pain and consist of four elements: cognitive anxiety, escape and avoidance, fearful appraisals of pain, and physiological anxiety.

Following scoring indicates severity of symptoms:

mild: 0 to 34 moderate: 35-67 severe 68-100
At baseline and after completion of study at sixth week
Change on Center for Epidemiological Studies-Depression scale in scores
Time Frame: At baseline and after completion of study at sixth week

A 20 items self-report scale that is used to assess depression related symptoms on the basis of frequency over the past week in primary care setting.

Following Scoring indicate severity:

0- 10 or less than 16 : little or no symptoms of depression 16-20 mild symptoms 22 - 25 moderate symptoms 26 -60 severe depression
At baseline and after completion of study at sixth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Hamna Syed, DPT, Dow University of Health Sciences
  • Study Director: Dr. Syed Imran Ahmed, MBBS,FCPS, Sindh Institute of Physical Medicine and Rehabilitation
  • Study Director: Dr, Naila Naeem Shahbaz, MBBS,FCPS, Dr. Ruth K.M. Pfau Civil Hospital, Karachi
  • Study Director: Aftab Ahmed Mirza Baig, DPT,MSAPT, Sindh Institute of Physical Medicine and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

April 9, 2022

First Submitted That Met QC Criteria

July 17, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 17, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HamnaS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carpal Tunnel Syndrome

Clinical Trials on Soft tissue mobilization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe