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

June 15, 2022 updated by: Riphah International University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sahiwal, Punjab, Pakistan, 57000
        • Recruiting
        • Al-Mahmood Welfare Foundation
        • Principal Investigator:
          • Sumaiya Naeem, MSPT-OMPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Sub Occipital Muscle Inhibition
Subjects in this group will receive only Sub Occipital Muscle Inhibition Technique and heating pad for 10 minutes.
Other: Sub Occipital Muscle Inhibition
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.
Experimental: Sub Occipital Inhibition with Hold Relax Agonist Contraction
Subjects in this group will receive Sub Occipital Inhibition and Hold Relax Agonist Contraction of hamstrings.
Other: Sub Occipital Muscle Inhibition
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.
Other: Sub Occipital Inhibition with Hold Relax Agonist Contraction
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: 2 weeks
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.
2 weeks
Bubble Inclinometer for Active Knee Extension test
Time Frame: 2 weeks

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)
2 weeks
Neck disability index
Time Frame: 2 weeks
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.
2 weeks
Image J software for Craniovertebral Angle
Time Frame: 2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/Lhr/22/0133 Sumaiya

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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