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Effect of Post Isometric Relaxation Versus Myofascial Release Therapy in the Management of Non Specific Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
1.Post Isometric Relaxation
1.Myofascial Release therapy
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Non specific neck pain, Post isometric relaxation, Muscle energy techniques, Myofascial Release therapy

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Non-specific neck pain for 2-6 weeks.
  2. Unilateral neck pain
  3. Patients' age group between 25 - 40.
  4. On VAS scale pain intensity >4.

Exclusion Criteria:

  1. Cervicogenic headache.
  2. Tumor of cervical spine.
  3. Whiplash injury.
  4. Cervical Fractures
  5. Normal ROM of cervical spine.

Sites / Locations

  • Dow university of health sciences & Institute of physical medicine and rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Post Isometric Relaxation

Myofascial Release Therapy

Arm Description

This study ARM will receive following therapies Post isometric relaxation (Upper Trapezius and Levator Scapulae muscles) Isometric neck strengthening exercises Cryotherapy

This study ARM will receive following therapies Myofascial release therapy (Upper Trapezius and Levator Scapulae muscles Isometric neck strengthening exercises Cryotherapy

Outcomes

Primary Outcome Measures

Neck Disability Index (NDI)
NDI is a condition specific or patient completed questionnaire comprising of 10 items to evaluate pain, and functional status which is mostly used for reporting neck pain. Each item on scale is scored from 0-5, where all the scores are added to total points and interpreted as percentages i.e. 0 point or 0% means no activity limitation and 50 points or 100% means complete activity limitation.

Secondary Outcome Measures

Visual Analogue Scale
It is 10cm or 10nm line psychometric response scale to measure pain. Aggregate score ranges from 0-10. Score 0-4 means mild pain, 4-7 means moderate pain and 7- 10 means severe pain
Range of Motion
The universal goniometer (UG) is a measuring tool commonly used in clinics, to measure active cervical range of motion (ACROM), UG will be used to measure cervical ranges in all directions i.e. flexion, extension, lateral flexion and rotation. To measure cervical flexion and extension the UG axis will be placed over the external auditory meatus and will asked the patient will be asked to flex and extend the head, for lateral flexion over centre of sternal notch and for the cervical rotation over the centre of subject's head
WHO Quality of life-BREF (WHOQOL BREF)
The WHOQOL-BREF is an instrument which is used to assess psychometric properties. Consisting of 26 questions related to the following 4 domains: physical, psychological health, social relationship and environment. Each item is rated on 5-point scoring scale where each score is transferred between 0 and 100.

Full Information

First Posted
November 16, 2020
Last Updated
July 27, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04638062
Brief Title
Effect of Post Isometric Relaxation Versus Myofascial Release Therapy in the Management of Non Specific Neck Pain
Official Title
Effect of Post Isometric Relaxation Versus Myofascial Release Therapy on Pain, Functional Disability and QoL in the Management of Non Specific Neck Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
November 20, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)

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
Yes

5. Study Description

Brief Summary
Non-specific neck pain (NS-NP) is the most prevailing musculoskeletal disorder (MSK) which has large socio-economic burden worldwide. It is associated with poor posture and neck strain which may lead to pain and restricted mobility. Post isometric relaxation a form of Muscle energy technique, that works on the principles of restoring biomechanics, reducing the movement restriction and pain. Myofascial release therapy will improve muscle immobility and pain by improving blood circulation lymphatic drainage and relaxing the contracted muscles. The aim of this study is to determine the effect of Post-isometric relaxation Versus Myofascial release therapy on pain, range of motion, disability and quality of life in the management of non-specific neck pain.
Detailed Description
A randomized control trial will be conducted at IPMR (Institute of Physical Medicine and Rehabilitation) on 60 patients with non-specific neck pain with age group between 25-40 years. Initial screening of the patients will be carried out by referring physiatrist. Patients who fulfils inclusion criteria will be randomly allocated to either group by computer generated random sampling after taking written informed consent. All the patients will be evaluated using Visual analogue scale for pain, Neck disability index for functional status and disability, Universal goniometer for cervical range of motion and WHO BREF for quality of life on 1st and 6th sessions. Group 1 will receive Post isometric relaxation for Upper trapezius and levator scapulae along with Cryotherapy and strengthening exercises . Group 2 will receive myofascial release therapy for Upper Trapezius and Levator scapulae muscles along with cryotherapy and strengthening exercises. Data will be analyzed using the SPSS version 21. Baseline reading will be taken for further comparison at the end of treatment. Baseline variables are Pain, ROM, Functional disability and Qol. For within group analysis, paired sample t test will be used. For intergroup independent sample t test will be used. P value less than 0.05 will be set as threshold to detect statistical significance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Non specific neck pain, Post isometric relaxation, Muscle energy techniques, Myofascial Release therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post Isometric Relaxation
Arm Type
Experimental
Arm Description
This study ARM will receive following therapies Post isometric relaxation (Upper Trapezius and Levator Scapulae muscles) Isometric neck strengthening exercises Cryotherapy
Arm Title
Myofascial Release Therapy
Arm Type
Experimental
Arm Description
This study ARM will receive following therapies Myofascial release therapy (Upper Trapezius and Levator Scapulae muscles Isometric neck strengthening exercises Cryotherapy
Intervention Type
Other
Intervention Name(s)
1.Post Isometric Relaxation
Intervention Description
For Upper Trapezius In supine position Neck flexion, contra-lateral full side bending followed by slight ipsilateral rotation will be provided towards the side being treated. while asking the patient to shrug the stabilized shoulder and contraction will be maintained for 7- 10s. Repeating it 3-5 times. For Levator Scapulae Step One In supine position while lifting the patients neck in full flexion, lateral flexion and rotation with 7-10s isometric contraction away from side to be treated will be provided. Step Two The patient will be instructed to take head backwards to the table while at the same time asking the patient to slightly shrug the shoulder and resistance will be provided. Repeating it 3-5 times. 2.Neck isometric strengthening exercises Intensity 5 reps Frequency at 1st week one set and second week will progress to 2 sets 3.Cryotherapy will be placed on cervical region for 10 min after the treatment.
Intervention Type
Other
Intervention Name(s)
1.Myofascial Release therapy
Intervention Description
For Upper Trapezius In sitting position Myofascial Release of Trapezius will be performed unilaterally with soft fist or elbow sinking and then taking up the line of tension from mid belly of Trapezius, to the acromion process, while the patient drops the head forward and will slowly rotate the head from side to side. While providing the resistance to contralateral side of rotation. Repeating for 2-3 times. For Levator Scapulae In sitting position applying same unilateral muscle release as Trapezius, but the line of tension will be to the inferior border of Scapulae slightly laterally and will ask the patient to drop the head forward to increase resistance on Levator muscle. Repeating it 2-3 times 2.Neck isometric strengthening exercises Intensity 5 reps Frequency at 1st week one set and second week will progress to 2 sets 3.Cryotherapy will be placed on cervical region for 10 min after the treatment.
Primary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
NDI is a condition specific or patient completed questionnaire comprising of 10 items to evaluate pain, and functional status which is mostly used for reporting neck pain. Each item on scale is scored from 0-5, where all the scores are added to total points and interpreted as percentages i.e. 0 point or 0% means no activity limitation and 50 points or 100% means complete activity limitation.
Time Frame
baseline and post intervention 2 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
It is 10cm or 10nm line psychometric response scale to measure pain. Aggregate score ranges from 0-10. Score 0-4 means mild pain, 4-7 means moderate pain and 7- 10 means severe pain
Time Frame
baseline and 2 weeks
Title
Range of Motion
Description
The universal goniometer (UG) is a measuring tool commonly used in clinics, to measure active cervical range of motion (ACROM), UG will be used to measure cervical ranges in all directions i.e. flexion, extension, lateral flexion and rotation. To measure cervical flexion and extension the UG axis will be placed over the external auditory meatus and will asked the patient will be asked to flex and extend the head, for lateral flexion over centre of sternal notch and for the cervical rotation over the centre of subject's head
Time Frame
baseline and 2 weeks
Title
WHO Quality of life-BREF (WHOQOL BREF)
Description
The WHOQOL-BREF is an instrument which is used to assess psychometric properties. Consisting of 26 questions related to the following 4 domains: physical, psychological health, social relationship and environment. Each item is rated on 5-point scoring scale where each score is transferred between 0 and 100.
Time Frame
baseline and 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-specific neck pain for 2-6 weeks. Unilateral neck pain Patients' age group between 25 - 40. On VAS scale pain intensity >4. Exclusion Criteria: Cervicogenic headache. Tumor of cervical spine. Whiplash injury. Cervical Fractures Normal ROM of cervical spine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zainab K Khan, MSAP
Organizational Affiliation
DUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow university of health sciences & Institute of physical medicine and rehabilitation
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Post Isometric Relaxation Versus Myofascial Release Therapy in the Management of Non Specific Neck Pain

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