search
Back to results

Comparative Effects of Myofascial Decompression and Positional Release Therapies in Chronic Non-specific Neck Pain

Primary Purpose

Chronic Non-specific Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Myofascial Decompression Therapy
positional Release Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non-specific Neck Pain focused on measuring non-specific neck pain, myofascial decompression therapy, positional release therapy

Eligibility Criteria

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

Inclusion Criteria: Neck patients age 25 to 50 years. Both male and female genders. Mild to moderate back pain with NPRS pain score value of between more than 6/10. Pain from at least past three months (12 weeks). Trigger points within the muscle. Exclusion Criteria: Diagnosis of systemic metabolic and/or neurological disorders. Patients with sensory impairments, such as diabetic sensory neuropathy. Neuropathic pain. Any referred pain or neurological involvement in lower limbs is not included.

Sites / Locations

  • Riphah international universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Myofascial Decompression Therapy

Positional Release technique

Arm Description

15 minute's moist heat will be given first. Patient was lied prone on couch with their upper torso unclothed, covered with massage oil than placed cup on skin and suction will created in cups by pump.

Positional Release technique (PRT) is apply after application of moist heat pack for 15 minute. The subjects received PRT will be in supine lying with the therapist sitting on the affected side, tender points were located along with the upper fibers of trapezius muscle. The subject's head was laterally flexed towards the side of tender point, then therapist grasps the subject's forearm and abducts shoulder to approximately 900 and adds slight flexion or extension to fine-tune.

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NPRS)
Numerical Rating Scale (NPRS) Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in neck pain .The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
Neck Disability Index (NDI)
The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain. Points summed to a total score The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.,0 points or 0% means : no activity limitations .50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. For patients' understanding, the URDU version is used. A clinically important change was calculated as 5 points, with a sensitivity of 0.78 and a specificity of 0.80

Secondary Outcome Measures

ROM cervical spine (flexion)
The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor for measuring range of cervical flexion
ROM cervical spine (extension)
The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and patient extend neck, for measuring the cervical extension ROM.
ROM cervical spine (side flexion)
The patient is seated with upper back supported with chair the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae so that arm is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance for side flexion
. ROM cervical spine (Rotation)
The patient is seated with upper back supported with a chair the center of the goniometer is placed Over center of cranial aspect of head, proximal arm is placed Parallel to imaginary line between the two acromial processes and distal arm With the tip of the nose. If using the tongue depressor, parallel to the longitudinal axis of tongue depressor for cervical rotation ROM.

Full Information

First Posted
June 14, 2023
Last Updated
July 7, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05947214
Brief Title
Comparative Effects of Myofascial Decompression and Positional Release Therapies in Chronic Non-specific Neck Pain
Official Title
Comparative Effects of Myofascial Decompression and Positional Release Therapies on Pain, Range of Motion and Functional Disability in Chronic Non-specific Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
August 12, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
Nonspecific neck pain is defined as a neck pain not attributable to an identifiable, known specific pathology. The frequency of neck pain as found to be 84% which is exceptionally high and these are the majority of the individuals with neck pain that present to physiotherapy. In many cases, various factors contribute to the development of non-specific neck pain. These might include physical strain at work, such as working on something above you or sitting at a desk without moving enough. Emotional stress, like worries and anxiety about family or work, often plays an important role. It is thought that in some cases the cause may be an over-stretch (sprain) of a ligament or muscle. In other cases the cause may be a minor problem with a disc between two spinal bones (vertebrae), or a minor problem with a small facet joint between two vertebrae. Objective of this study will be to compare the effects of myofascial decompression and positional release therapies on pain, range of motion and functional disability in chronic nonspecific neck pain.
Detailed Description
Neck pain is one of the most common and painful musculoskeletal conditions. Point prevalence ranges from 6% to 22% and up to 38% of the elderly population, while lifetime prevalence ranges from 2% to 71%. For the majority of the neck disorders there is an absence of an identifiable underlying disease or abnormal anatomical structure. From this perspective .NS-NP is mainly 'diagnosed' on the basis of clinical grounds, provided there are no features to suggest a specific or more serious condition. The symptoms of nonspecific neck pain are similar to those of whiplash associated disorders (WAD) grade I and II but there is no traumatic event involved. Nonspecific neck pain (NP) is defined as pain in the posterior and lateral aspect of the neck between the superior nuchal line and the spinous process of the first thoracic vertebra with no signs or symptoms of major structural pathology and no or minor to major interference with activities of daily life as well as with the absence of neurological signs and specific pathologies. Chronic nonspecific neck pain is diagnosed as cervical pain without a known pathological basis as the underlying cause of the complaints. Some symptoms are limited cervical spine mobility and neck muscles weakness, which may be often related to other problems, such as, vertebral, neck or shoulder impaired function, and mental and physical stress at work. The natural course of non-specific neck pain remains unclear. While it is often self-limiting within a few weeks of onset, it can severely limit daily functioning, induce substantial medical consumption and result in prolonged sick leave and disability leading chronic nonspecific neck pain if pain duration is more than three months. As a consequence, it places a heavy burden on individuals, employers and health care services. Nonspecific neck pain is defined in the European guidelines for the management of chronic nonspecific neck pain that is not attributable to a recognizable, specific pathology (e.g., infection, tumor, osteoporosis, fracture, structural deformity, and inflammatory diseases, such as ankylosing spondylitis, radicular syndrome. Characteristic of chronic nonspecific neck pain are heavy pain, worsening with exertion and relieve with rest. In some cases the cause may be sprain or overstretch of a ligament or muscles. Nonspecific neck belongs to the group of musculoskeletal disorders, which include diverse conditions affecting muscles, bones, and/or joints of the limbs or the spine. As for most other musculoskeletal disorders, nonspecific neck is multifactorial. A variety of different types of exercise have been explored to treat chronic neck pain, including low-to-moderate intensity aerobic exercise, high intensity aerobic exercise, stretching exercise and muscular strength exercises and isometrics. However, the most effective form of exercise as a method of rehabilitation non-specific neck pain is unknown reflecting its complexity and more research is require. The rationale of the study is to compare the effects of myofascial decompression and positional release therapies on pain, range of motion and functional disability in chronic nonspecific neck pain. The main purpose of myofascial decompression therapy and positional release therapy is to release the cervical trigger points, improving end ranges and lengthening of muscle. MDT helps draw toxins out of the muscles and to the superficial veins to be removed by the body. This leads to decreased pain and tension in the tissues. The ultimate goal is to achieve pain free end ranges and flexibility of muscle in nonspecific neck pain patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific Neck Pain
Keywords
non-specific neck pain, myofascial decompression therapy, positional release therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Myofascial Decompression Therapy
Arm Type
Experimental
Arm Description
15 minute's moist heat will be given first. Patient was lied prone on couch with their upper torso unclothed, covered with massage oil than placed cup on skin and suction will created in cups by pump.
Arm Title
Positional Release technique
Arm Type
Experimental
Arm Description
Positional Release technique (PRT) is apply after application of moist heat pack for 15 minute. The subjects received PRT will be in supine lying with the therapist sitting on the affected side, tender points were located along with the upper fibers of trapezius muscle. The subject's head was laterally flexed towards the side of tender point, then therapist grasps the subject's forearm and abducts shoulder to approximately 900 and adds slight flexion or extension to fine-tune.
Intervention Type
Other
Intervention Name(s)
Myofascial Decompression Therapy
Intervention Description
Group A will be given myofascial decompression therapy.15 minute's moist heat will be given first. Patient was lied prone on couch with their upper torso unclothed, covered with massage oil than placed cup on skin and suction will created by pump. Than drawn over skin along the spine from cervical to thoracic up to lateral border maintain the suction within skin throughout the procedure. The cup massage will conducted for approximately 10 minutes. Patients were informed that the treatment area may become patchy and there are chances of ecchymosis on the same area.
Intervention Type
Other
Intervention Name(s)
positional Release Therapy
Intervention Description
Group B will be given Positional Release technique (PRT) after application of moist heat pack for 15 minute. The subjects received PRT will be in supine lying with the therapist sitting on the affected side, tender points were located along with the upper fibers of trapezius muscle. The subject's head was laterally flexed towards the side of tender point, then therapist grasps the subject's forearm and abducts shoulder to approximately 90 degree and adds slight flexion or extension to fine-tune. The ideal position of comfort achieved was held for a period of 90 sec and followed by passive return of body part to an anatomically neutral position continued for 5 minutes. Treatment duration was 3 sessions per week for 4 weeks.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NPRS)
Description
Numerical Rating Scale (NPRS) Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in neck pain .The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
Time Frame
6th week
Title
Neck Disability Index (NDI)
Description
The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain. Points summed to a total score The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.,0 points or 0% means : no activity limitations .50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. For patients' understanding, the URDU version is used. A clinically important change was calculated as 5 points, with a sensitivity of 0.78 and a specificity of 0.80
Time Frame
6th week
Secondary Outcome Measure Information:
Title
ROM cervical spine (flexion)
Description
The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor for measuring range of cervical flexion
Time Frame
6th week
Title
ROM cervical spine (extension)
Description
The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and patient extend neck, for measuring the cervical extension ROM.
Time Frame
6th week
Title
ROM cervical spine (side flexion)
Description
The patient is seated with upper back supported with chair the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae so that arm is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance for side flexion
Time Frame
6th week
Title
. ROM cervical spine (Rotation)
Description
The patient is seated with upper back supported with a chair the center of the goniometer is placed Over center of cranial aspect of head, proximal arm is placed Parallel to imaginary line between the two acromial processes and distal arm With the tip of the nose. If using the tongue depressor, parallel to the longitudinal axis of tongue depressor for cervical rotation ROM.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neck patients age 25 to 50 years. Both male and female genders. Mild to moderate back pain with NPRS pain score value of between more than 6/10. Pain from at least past three months (12 weeks). Trigger points within the muscle. Exclusion Criteria: Diagnosis of systemic metabolic and/or neurological disorders. Patients with sensory impairments, such as diabetic sensory neuropathy. Neuropathic pain. Any referred pain or neurological involvement in lower limbs is not included.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sana Hafeez, PHD*
Phone
03234195603
Email
Sana.hafeez@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
maham Naeem, MS(OMPT)*
Phone
03330366524
Email
mahamnaeem368@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sana Hafeez, PhD*
Organizational Affiliation
Riphah International University Lahore Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah international university
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sana Hafeez, PHD*
Phone
03234195603
Email
Sana.hafeez@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Maham Naeem, MS(OMPT)*
Phone
03330366524
Email
mahamnaeem368@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Effects of Myofascial Decompression and Positional Release Therapies in Chronic Non-specific Neck Pain

We'll reach out to this number within 24 hrs