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

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466162
• Other study ID #: HamnaS
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2021
• Est. completion date: August 2022

Study information

• Verified date: July 2022
• Source: Dow University of Health Sciences
• Contact: Hamna Syed, DPT
• Phone: +923043257150
• Email: hamnasyyd6[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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
• 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.

Locations

Country	Name	City	State
Pakistan	Sindh Institute of Physical Medicine and Rehabilitation	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change on Pain Anxiety Symptoms Scale-20	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
Other	Change on Center for Epidemiological Studies-Depression scale in scores	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
Primary	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.	At baseline and after completion of study at after sixth week
Primary	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.	At baseline and after completion of study at after sixth week
Primary	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.	At baseline and after completion of study at sixth week
Primary	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.	At baseline and after completion of study at sixth week