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

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Soft tissue mobilization
Joint and nerve mobilization
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring peripheral neuropathy, compression neuropathy, entrapment neuropathy, soft tissue massage, manual therapy, massage therapy, Median neuropathy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sindh Institute of Physical Medicine and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Soft tissue mobilization + joint and nerve Mobilization

joint and nerve mobilizations

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in pain intensity on Visual Analog Scale in centimeter 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.
Change in symptoms severity and functional status on scale of Boston Carpal Tunnel Questionnaire in scores
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.
Change in hand grip strength by using Jamar dynamometer
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.
Change in pinch strength by using Pinch Gauge
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.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2022
Last Updated
July 17, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05466162
Brief Title
Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome
Official Title
Effects of Soft Tissue Massage Along With Mobilization Technique on Intensity of Symptoms and Functional Status of Carpal Tunnel Syndrome - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
peripheral neuropathy, compression neuropathy, entrapment neuropathy, soft tissue massage, manual therapy, massage therapy, Median neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a randomized controlled trial. Total 60 patients will be recruited, 30 in each group that includes There will be one interventional group and one control group. Treatment will be allocated by using a random number sheet generated by SPSS software version 21. Participants are assigned to one of two groups in parallel for the duration of the study.
Masking
Outcomes Assessor
Masking Description
The interventions assigned to individual participants will be kept hidden from the outcome assessors in the clinical trial.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Soft tissue mobilization + joint and nerve Mobilization
Arm Type
Experimental
Arm Description
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.
Arm Title
joint and nerve mobilizations
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Soft tissue mobilization
Other Intervention Name(s)
Nerve mobilization( Slider technique), Joint mobilization
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Joint and nerve mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain intensity on Visual Analog Scale in centimeter after sixth week
Description
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.
Time Frame
At baseline and after completion of study at after sixth week
Title
Change in symptoms severity and functional status on scale of Boston Carpal Tunnel Questionnaire in scores
Description
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.
Time Frame
At baseline and after completion of study at after sixth week
Title
Change in hand grip strength by using Jamar dynamometer
Description
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.
Time Frame
At baseline and after completion of study at sixth week
Title
Change in pinch strength by using Pinch Gauge
Description
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.
Time Frame
At baseline and after completion of study at sixth week
Other Pre-specified Outcome Measures:
Title
Change on Pain Anxiety Symptoms Scale-20
Description
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
Time Frame
At baseline and after completion of study at sixth week
Title
Change on Center for Epidemiological Studies-Depression scale in scores
Description
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
Time Frame
At baseline and after completion of study at sixth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamna Syed, DPT
Phone
+923043257150
Email
hamnasyyd6@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr.Syed Imran Ahmed, MBBS,FCPS
Phone
03002120661
Email
syedimran77@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamna Syed, DPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Syed Imran Ahmed, MBBS,FCPS
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dr, Naila Naeem Shahbaz, MBBS,FCPS
Organizational Affiliation
Dr. Ruth K.M. Pfau Civil Hospital, Karachi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, DPT,MSAPT
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Sindh Institute of Physical Medicine and Rehabilitation
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamna Syed, DPT
Phone
03043257150
Email
hamnasyyd6@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr.Syed Imran Ahmed, MBBS,FCPS
Phone
03002120661
Email
syedimran77@gmail.com
First Name & Middle Initial & Last Name & Degree
Hamna Syed, DPT
First Name & Middle Initial & Last Name & Degree
Dr. Syed Imran Ahmed, MBBS,FCPS
First Name & Middle Initial & Last Name & Degree
Dr. Naila Naeem Shahbaz, MBBS,FCPS
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, DPT,MSAPT

12. IPD Sharing Statement

Plan to Share IPD
No
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Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome

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