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Sub-Occipital MIT With and Without HR Agonist Contraction of Hamstrings in Neck Pain Patients With Hamstring Tightness

Primary Purpose

Neck Pain Patients With Hamstring Tightness

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Sub Occipital Muscle Inhibition
Sub Occipital Inhibition with Hold Relax Agonist Contraction
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain Patients With Hamstring Tightness focused on measuring Hamstring Muscles, Neck Pain, Muscle Tightness, PNF Stretching, Range of Motion

Eligibility Criteria

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

Inclusion Criteria:

Age 25-40 years Both Genders ( Male and Female) Neck Pain on NPRS ≥5 NDI score ≥14 ( Moderate disability) Active knee extension lag ≥30 and considered as tight hamstrings

Exclusion Criteria:

Acute Low back or Neck pain History of lumbar and cervical herniated disc and spinal stenosis History of cervical spine surgery and Trauma History of vascular disease in head and neck Progressive neurological deficit or Inflammatory condition ( such as peripheral neuropath, rheumatoid arthritis) History of abdominal or pelvic surgery in last 6 months

Sites / Locations

  • Al-Mahmood Welfare FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Sub Occipital Muscle Inhibition

Sub Occipital Inhibition with Hold Relax Agonist Contraction

Arm Description

Subjects in this group will receive only Sub Occipital Muscle Inhibition Technique and heating pad for 10 minutes.

Subjects in this group will receive Sub Occipital Inhibition and Hold Relax Agonist Contraction of hamstrings.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
The NPRS is an 11-point numerical scale used to measure average pain experience over 7 days, and ranges from 0 (no pain) to 11 (worst imaginable pain). NPRS is considered a valid and reliable scale for measures of pain intensity.
Bubble Inclinometer for Active Knee Extension test
For popliteal angle and cervical range of motion bubble inclinometer will be used in this study. In the Active knee extension test, the subjects knee will be extended with the subject will lying in the supine position and the hip joint flexed to 90°. This test has good validity and reliability (0.75)
Neck disability index
Urdu version of neck disability index will be used in this study.It consists of ten items related to pain intensity, headache, concentration and different physical activities (lifting, personal care, recreation, work, driving, reading and sleeping) with six possible responses per item. The score of each item ranges from 0 to 5. The highest total possible score is 50, and this score is converted to a percentage. Higher scores represent higher levels of disability. The NDI has been shown to be a valid and reliable questionnaire for patients with neck pain.
Image J software for Craniovertebral Angle
Craniovertebral angle will be measured by using a camera and Image J analysis software. For this purpose, patient will sit on a stool or chair in comfortable position, hands should be relaxed on thighs and feet on floor. A camera will set at I meter distance from patient and perpendicular to the height of patient's shoulder. The measuring evaluator attached two body markers, one on the tragus of ear and the other on the seventh spinous process. Patients will be asked to fix their gaze on a mark on the wall directly in front of them. Once the photograph was obtained, the CVA was used to measure the angle between a line extending from the tragus of the ear to C7 and the horizontal line passing through the C7 spinous process.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2022
Last Updated
June 15, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05353075
Brief Title
Sub-Occipital MIT With and Without HR Agonist Contraction of Hamstrings in Neck Pain Patients With Hamstring Tightness
Official Title
Effects of Sub-Occipital Muscle Inhibition Technique With and Without Hold Relax Agonist Contraction of Hamstrings on Pain, Disability and Craniovertebral Angle in Neck Pain Patients With Hamstring Tightness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
December 25, 2022 (Anticipated)
Study Completion Date
January 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
Hamstrings and Sub occipital muscles are part of the superficial back line of the myofascial chain which connects the neck to the lower extremity and the soft tissue in the cervical spine links the dura and sub occipital muscle fascia. Increased tension in one or other part of this myofascial chain disturbs the whole superficial back line and compromises the flexibility. The objective of this study is to determine the Effects of Sub-Occipital Muscle Inhibition technique (MIT) with and without Hold Relax (HR) Agonist Contraction of Hamstrings on Pain, Disability and Craniovertebral angle in Neck pain patients with Hamstring Tightness. This study will be a randomized controlled trial and will be conducted in Physiotherapy center of AL-Mahmood Welfare Foundation Sahiwal. This study will be completed in time duration of 10 months after the approval of synopsis and consecutive sampling technique will be used. A sample size of 34 will be randomly assigned into two groups. Group A will be given Sub Occipital Muscle Inhibition treatment while Group B will be given Sub occipital Muscle Inhibition and Hold Relax Agonist Contraction of hamstring. Each group will be given three sessions per week. Data will be collected from all participants before first session of treatment and after 6th session of treatment by using Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), Cervical Range of motion (CROM), Craniovertebral Angle (CVA) and Active knee extension (AKE) test measurement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain Patients With Hamstring Tightness
Keywords
Hamstring Muscles, Neck Pain, Muscle Tightness, PNF Stretching, Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sub Occipital Muscle Inhibition
Arm Type
Other
Arm Description
Subjects in this group will receive only Sub Occipital Muscle Inhibition Technique and heating pad for 10 minutes.
Arm Title
Sub Occipital Inhibition with Hold Relax Agonist Contraction
Arm Type
Experimental
Arm Description
Subjects in this group will receive Sub Occipital Inhibition and Hold Relax Agonist Contraction of hamstrings.
Intervention Type
Other
Intervention Name(s)
Sub Occipital Muscle Inhibition
Intervention Description
The therapist sits at the head end of the table, palms beneath the subject's head, pads of his fingertips on the posterior arch of the atlas, which will be palpated by the therapist between the external occipital protuberance and the spinous process of the axis vertebra. The therapist locates the gap between the occipital condyles and the spinous phase of the C2 vertebra with the middle and ring fingers of both hands the therapist then rests the base of the skull on his or her hands, with toward the therapist. The pressure will be held at the same level for four minutes until tissue relaxation will be achieved. The subject will be asked to keep his eyes closed during the SMI technique to prevent eye movements disturbing the Sub occipital muscle tone.
Intervention Type
Other
Intervention Name(s)
Sub Occipital Inhibition with Hold Relax Agonist Contraction
Intervention Description
Therapist will passively flex the lower extremity with knee extended to the end range of Hip Flexion. Once the end range of motion will attain the patient will apply a 10second isometric force against the therapist manual resistance. After the isometric contraction of hamstring the patient will ask to perform a concentric contraction of opposing muscle (hip flexors) for 10 seconds. As the patient performs the concentric contraction the therapist takes up the slack into any ROM that was gained keeping limb into new stretch position for 10-15 seconds and then rest for 5 seconds. Three repetitions of this technique will be performed on each subject.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
The NPRS is an 11-point numerical scale used to measure average pain experience over 7 days, and ranges from 0 (no pain) to 11 (worst imaginable pain). NPRS is considered a valid and reliable scale for measures of pain intensity.
Time Frame
2 weeks
Title
Bubble Inclinometer for Active Knee Extension test
Description
For popliteal angle and cervical range of motion bubble inclinometer will be used in this study. In the Active knee extension test, the subjects knee will be extended with the subject will lying in the supine position and the hip joint flexed to 90°. This test has good validity and reliability (0.75)
Time Frame
2 weeks
Title
Neck disability index
Description
Urdu version of neck disability index will be used in this study.It consists of ten items related to pain intensity, headache, concentration and different physical activities (lifting, personal care, recreation, work, driving, reading and sleeping) with six possible responses per item. The score of each item ranges from 0 to 5. The highest total possible score is 50, and this score is converted to a percentage. Higher scores represent higher levels of disability. The NDI has been shown to be a valid and reliable questionnaire for patients with neck pain.
Time Frame
2 weeks
Title
Image J software for Craniovertebral Angle
Description
Craniovertebral angle will be measured by using a camera and Image J analysis software. For this purpose, patient will sit on a stool or chair in comfortable position, hands should be relaxed on thighs and feet on floor. A camera will set at I meter distance from patient and perpendicular to the height of patient's shoulder. The measuring evaluator attached two body markers, one on the tragus of ear and the other on the seventh spinous process. Patients will be asked to fix their gaze on a mark on the wall directly in front of them. Once the photograph was obtained, the CVA was used to measure the angle between a line extending from the tragus of the ear to C7 and the horizontal line passing through the C7 spinous process.
Time Frame
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: Age 25-40 years Both Genders ( Male and Female) Neck Pain on NPRS ≥5 NDI score ≥14 ( Moderate disability) Active knee extension lag ≥30 and considered as tight hamstrings Exclusion Criteria: Acute Low back or Neck pain History of lumbar and cervical herniated disc and spinal stenosis History of cervical spine surgery and Trauma History of vascular disease in head and neck Progressive neurological deficit or Inflammatory condition ( such as peripheral neuropath, rheumatoid arthritis) History of abdominal or pelvic surgery in last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saima Zahid, PhD*
Phone
03334349520
Email
Saima.zahid@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saima Zahid, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Mahmood Welfare Foundation
City
Sahiwal
State/Province
Punjab
ZIP/Postal Code
57000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saima Zahid, PhD*
Phone
03334349520
Email
saima.zahid@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Sumaiya Naeem, MSPT-OMPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28602744
Citation
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Results Reference
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Onat SS, Polat CS, Bicer S, Sahin Z, Tasoglu O. Effect of Dry Needling Injection and Kinesiotaping on Pain and Quality of Life in Patients with Mechanical Neck Pain. Pain Physician. 2019 Nov;22(6):583-589.
Results Reference
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PubMed Identifier
27261928
Citation
Kim BB, Lee JH, Jeong HJ, Cynn HS. Effects of suboccipital release with craniocervical flexion exercise on craniocervical alignment and extrinsic cervical muscle activity in subjects with forward head posture. J Electromyogr Kinesiol. 2016 Oct;30:31-7. doi: 10.1016/j.jelekin.2016.05.007. Epub 2016 May 24.
Results Reference
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PubMed Identifier
25642072
Citation
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Citation
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Results Reference
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PubMed Identifier
34639438
Citation
Kwon SH, Chung EJ, Lee J, Kim SW, Lee BH. The Effect of Hamstring Relaxation Program on Headache, Pressure Pain Threshold, and Range of Motion in Patients with Tension Headache: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 27;18(19):10137. doi: 10.3390/ijerph181910137.
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34151831
Citation
Jeong ED, Kim CY, Kim NH, Kim HD. Immediate effects of static and proprioceptive neuromuscular facilitation stretching of hamstring muscles on straight leg raise, craniovertebral angle, and cervical spine range of motion in neck pain patients with hamstring tightness: A prospective randomized controlled trial. J Back Musculoskelet Rehabil. 2022;35(2):429-438. doi: 10.3233/BMR-201840.
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Sub-Occipital MIT With and Without HR Agonist Contraction of Hamstrings in Neck Pain Patients With Hamstring Tightness

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