Back to resultsEffect of Instrument-assisted Soft Tissue Mobilization Versus Myofascial Release in Treatment of Mechanical Neck Pain
Primary Purpose
Neck Pain, Soft Tissue Injuries
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Instrument-assisted soft tissue mobilization
Myofascial release therapy
Postural correction exercises (PCE)
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
Inclusion Criteria:
- Patient's age will be between 18-25 years old.
- Subjects with mechanical neck pain localized to cervical and periscapular region.
- Subjects with at least one trigger point in the upper trapezius and/or levator scapulae muscles
- Subjects should report mechanical neck pain of at least 30 mm on a visual analogue scale (VAS). The scale is ranged from 0 mm (no pain) to 100 mm (worst imaginable pain).
- Subjects who use computers daily for at least two hours and are involved in distance learning for at least three months.
Exclusion Criteria:
- Any specific neck pathology as radiculopathy, rheumatoid arthritis, and systemic diseases.
- Sensory problems at mid or upper back
- A tendency to hemorrhage or anticoagulation treatment. And nonsteroidal pain medication
- History of head and upper trunk trauma or surgery.
- Signs of severe pathology such as malignancy, fractures of the cervical spine, cervical radiculopathy or myelopathy, or vascular syndromes such as vertebrobasilar insufficiency.
Sites / Locations
- Outpatient clinic, Faculty of Physical Therapy, Misr university for scientific and technology, Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IASTM group
myofascial release group
Arm Description
Group (A) will receive IASTM on the right upper trapezius and levator scapulae twice a week for four weeks in addition to a postural correction program.
Group (B) will receive a myofascial release on the right upper trapezius and levator scapulae twice a week for four weeks in addition to the postural correction program.
Outcomes
Primary Outcome Measures
Pain intensity assessment
Assessing the change in pain intensity via using visual analogue scale which will be used to examine pain intensity. It consists of a continuous 10 cm line. The patient will be instructed to place a vertical mark on the line to indicate his/her pain, ranging from no pain or discomfort (0), to the worst pain he/she could possibly feel . Using the visual analogue scale allows the patient freedom to record and not restricting him by numbers.
Neck disability index
Assessing the change in neck disability via using Neck disability index which is is a self-reported outcome measure which is commonly used to determine the perceived disability in patients with neck pain. It consists of 10 items; 7 related to activities of daily living, (ADL), 2 related to pain, and 1 related to concentration. Each item is scored from 0-5 and the total score is expressed as percentage, with higher scores corresponding to greater disability.
Muscle pressure intensity
Assessing the change in Muscle pressure intensity via using Pressure Algometer which is a handheld device that applies a manual pressure stimulus to assess pressure intensity. It has been broadly used and validated. A pressure threshold algometer will be used to measure the pressure pain threshold of a Trigger points of the upper trapezius and levator scapulae muscle before and aftertreatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05213871
Brief Title
Effect of Instrument-assisted Soft Tissue Mobilization Versus Myofascial Release in Treatment of Mechanical Neck Pain
Official Title
Effect of Instrument-assisted Soft Tissue Mobilization Versus Myofascial Release in Treatment of Mechanical Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
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
Mechanical neck pain has become a major health problem recently, affecting around one-year prevalence ranging from 42 to 67% in young adults aged 20-24 years causing pain and functional deficits. No study has been conducted before to investigate the effect of Instrument assisted soft tissue mobilization (IASTM) with mechanical neck pain on university students involved in distance learning.
Detailed Description
Mechanical neck pain is a major social and economic burden. It showed a one-year prevalence ranging from 42 to 67% in young adults aged 20-24 years. Treatment of neck pain is costly in terms of utilization of health care services, disability, compensation payments and lost work productivity. With the increasing prevalence of pain and disability associated with musculoskeletal impairments, it is essential to identify the most efficacious interventions to maximize patient outcomes and decrease the societal burden.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Soft Tissue Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IASTM group
Arm Type
Experimental
Arm Description
Group (A) will receive IASTM on the right upper trapezius and levator scapulae twice a week for four weeks in addition to a postural correction program.
Arm Title
myofascial release group
Arm Type
Experimental
Arm Description
Group (B) will receive a myofascial release on the right upper trapezius and levator scapulae twice a week for four weeks in addition to the postural correction program.
Intervention Type
Other
Intervention Name(s)
Instrument-assisted soft tissue mobilization
Intervention Description
For IASTM, the subject will be seated in a comfortable position. The subject's forehead will be rested on his/her forearm on a table in front of him/her. A lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2T blade will be cleaned with an alcohol pad. The M2T blade will be used, at an angle of 45 without causing discomfort or pain, from the muscle origin to its insertion (sweeping technique), for approximately 3 min. Subjects will be instructed to put an ice pack on the area if they feel any burning sensations after the session. This procedure will be repeated twice a week for four weeks.
Intervention Type
Other
Intervention Name(s)
Myofascial release therapy
Intervention Description
Firstly, the subject will lay supine with no pillow under his/ her head then the subject will rotate his/her head and neck away from the side which will be treated. Therapist will sit or stand at the corner, edge or top of the treatment table and therapist will place one hand proximal to the shoulder with skin on skin and therapist's fingers pointing towards the subject's elbow on the same side. Other hand of the therapist will be placed inferior to the subject's jaw (body of the mandible), using it as a handle, with fingers pointing towards the top of the subject's head. Then therapist will lean into the subject to the tissue depth barrier, wait and follow each subtle release three-dimensionally. Therapist should avoid forcing the tissue or slipping or gliding over the skin. The technique should be applied for at least five minutes for optimal results. This procedure will be repeated twice a week for four weeks.
Intervention Type
Other
Intervention Name(s)
Postural correction exercises (PCE)
Intervention Description
Postural correction exercises will be applied for patients in groups A and B. This program will be conducted according to the protocols of exercise will be performed as 3 sets of 10 repetitions each for 2 times/ week for 4 weeks. The patients will be instructed to continue the exercises as a daily home program to influence the self-correction kinesthetic awareness. Exercises will be performed while the patients in a neutral sitting posture
Primary Outcome Measure Information:
Title
Pain intensity assessment
Description
Assessing the change in pain intensity via using visual analogue scale which will be used to examine pain intensity. It consists of a continuous 10 cm line. The patient will be instructed to place a vertical mark on the line to indicate his/her pain, ranging from no pain or discomfort (0), to the worst pain he/she could possibly feel . Using the visual analogue scale allows the patient freedom to record and not restricting him by numbers.
Time Frame
at baseline and after 4 weeks of intervention
Title
Neck disability index
Description
Assessing the change in neck disability via using Neck disability index which is is a self-reported outcome measure which is commonly used to determine the perceived disability in patients with neck pain. It consists of 10 items; 7 related to activities of daily living, (ADL), 2 related to pain, and 1 related to concentration. Each item is scored from 0-5 and the total score is expressed as percentage, with higher scores corresponding to greater disability.
Time Frame
at baseline and after 4 weeks of intervention
Title
Muscle pressure intensity
Description
Assessing the change in Muscle pressure intensity via using Pressure Algometer which is a handheld device that applies a manual pressure stimulus to assess pressure intensity. It has been broadly used and validated. A pressure threshold algometer will be used to measure the pressure pain threshold of a Trigger points of the upper trapezius and levator scapulae muscle before and aftertreatment.
Time Frame
at baseline and after 4 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient's age will be between 18-25 years old.
Subjects with mechanical neck pain localized to cervical and periscapular region.
Subjects with at least one trigger point in the upper trapezius and/or levator scapulae muscles
Subjects should report mechanical neck pain of at least 30 mm on a visual analogue scale (VAS). The scale is ranged from 0 mm (no pain) to 100 mm (worst imaginable pain).
Subjects who use computers daily for at least two hours and are involved in distance learning for at least three months.
Exclusion Criteria:
Any specific neck pathology as radiculopathy, rheumatoid arthritis, and systemic diseases.
Sensory problems at mid or upper back
A tendency to hemorrhage or anticoagulation treatment. And nonsteroidal pain medication
History of head and upper trunk trauma or surgery.
Signs of severe pathology such as malignancy, fractures of the cervical spine, cervical radiculopathy or myelopathy, or vascular syndromes such as vertebrobasilar insufficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Hanafy
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic, Faculty of Physical Therapy, Misr university for scientific and technology, Egypt
City
Cairo
ZIP/Postal Code
34518
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Instrument-assisted Soft Tissue Mobilization Versus Myofascial Release in Treatment of Mechanical Neck Pain
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