Clinical trial NCT05466162: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: peripheral neuropathy
compression neuropathy
entrapment neuropathy
soft tissue massage
manual therapy
massage therapy
Median neuropathy
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in pain intensity on Visual Analog Scale in centimeter after sixth week
timeFrame: At baseline and after completion of study at after sixth week
measure: Change in symptoms severity and functional status on scale of Boston Carpal Tunnel Questionnaire in scores
timeFrame: At baseline and after completion of study at after sixth week
measure: Change in hand grip strength by using Jamar dynamometer
timeFrame: At baseline and after completion of study at sixth week
measure: Change in pinch strength by using Pinch Gauge
timeFrame: At baseline and after completion of study at sixth week
Secondary outcomes:
Other outcomes:
measure: Change on Pain Anxiety Symptoms Scale-20
timeFrame: At baseline and after completion of study at sixth week
measure: Change on Center for Epidemiological Studies-Depression scale in scores
timeFrame: At baseline and after completion of study at sixth week
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute of Physical Medicine and Rehabilitation
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Hamna Syed, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Sindh Institute of Physical Medicine and Rehabilitation
name: Dr. Syed Imran Ahmed, MBBS,FCPS
role: STUDY_DIRECTOR
affiliation: Dr. Ruth K.M. Pfau Civil Hospital, Karachi
name: Dr, Naila Naeem Shahbaz, MBBS,FCPS
role: STUDY_DIRECTOR
affiliation: Sindh Institute of Physical Medicine and Rehabilitation
name: Aftab Ahmed Mirza Baig, DPT,MSAPT
role: STUDY_DIRECTOR
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