Neck Pain Patients With Hamstring TightnessNCT05353075

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

A study testing Sub Occipital Muscle Inhibition and Sub Occipital Inhibition with Hold Relax Agonist Contraction in people with Neck Pain Patients With Hamstring Tightness, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 25 to 40 years
Conditions the study is for: Neck Pain Patients With Hamstring Tightness
What is being tested?: Sub Occipital Muscle Inhibition and Sub Occipital Inhibition with Hold Relax Agonist Contraction
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 sitePakistan
Study dates: 25 Apr 2022to 10 Jan 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Saima Zahid, PhD* contact

03334349520

Saima.zahid@riphah.edu.pk

Pakistan1 site, 1 recruiting

Al-Mahmood Welfare Foundation
Sahiwal, Punjab Province, 57000
Saima Zahid, PhD*, 03334349520, saima.zahid@riphah.edu.pk
Sumaiya Naeem, MSPT-OMPT
Recruiting

Other trials in Pakistan

About this study

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

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.

Conditions: Neck Pain Patients With Hamstring Tightness
Being tested: Sub Occipital Muscle Inhibition, Sub Occipital Inhibition with Hold Relax Agonist Contraction
Keywords: Hamstring Muscles, Neck Pain, Muscle Tightness, PNF Stretching, Range of Motion
Medical subject headings: Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sub Occipital Muscle InhibitionOther
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.
Sub Occipital Inhibition with Hold Relax Agonist ContractionOther
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.

Study groups in NCT05353075
Study group	Role	What they receive
Sub Occipital Muscle Inhibition	Other	Subjects in this group will receive only Sub Occipital Muscle Inhibition Technique and heating pad for 10 minutes. Receives: Other: Sub Occipital Muscle Inhibition
Sub Occipital Inhibition with Hold Relax Agonist Contraction	Experimental	Subjects in this group will receive Sub Occipital Inhibition and Hold Relax Agonist Contraction of hamstrings. Receives: Other: Sub Occipital Muscle Inhibition; Other: Sub Occipital Inhibition with Hold Relax Agonist Contraction

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 weeks
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)
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 202210 Jan 2023

First posted29 Apr 2022
Study start25 Apr 2022
Primary completion25 Dec 2022 (estimated)
Study completion10 Jan 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Neck Pain Patients With Hamstring TightnessStudies of the same condition, open and under way.
More trials run by Riphah International UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05353075
Sponsor's protocol ID: REC/Lhr/22/0133 Sumaiya
Status last verified: Jun 2022
First submitted: 21 Apr 2022
Last updated: 16 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.
PubMed 28602744
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.
PubMed 31775405
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.
PubMed 27261928
Cho SH, Kim SH, Park DJ. The comparison of the immediate effects of application of the suboccipital muscle inhibition and self-myofascial release techniques in the suboccipital region on short hamstring. J Phys Ther Sci. 2015 Jan;27(1):195-7. doi: 10.1589/jpts.27.195. Epub 2015 Jan 9.
PubMed 25642072
Jeong ED, Kim CY, Kim SM, Lee SJ, Kim HD. Short-term effects of the suboccipital muscle inhibition technique and cranio-cervical flexion exercise on hamstring flexibility, cranio-vertebral angle, and range of motion of the cervical spine in subjects with neck pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2018;31(6):1025-1034. doi: 10.3233/BMR-171016.
PubMed 30248030
Dhiman NR, Das B, Mohanty C, Singh OP, Gyanpuri V, Raj D. Myofascial release versus other soft tissue release techniques along superficial back line structures for improving flexibility in asymptomatic adults: A systematic review with meta-analysis. J Bodyw Mov Ther. 2021 Oct;28:450-457. doi: 10.1016/j.jbmt.2021.06.026. Epub 2021 Jun 16.
PubMed 34776177
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.
PubMed 34639438
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.
PubMed 34151831
Joshi DG, Balthillaya G, Prabhu A. Effect of remote myofascial release on hamstring flexibility in asymptomatic individuals - A randomized clinical trial. J Bodyw Mov Ther. 2018 Jul;22(3):832-837. doi: 10.1016/j.jbmt.2018.01.008. Epub 2018 Feb 17.
PubMed 30100320
Wilke J, Vogt L, Niederer D, Banzer W. Is remote stretching based on myofascial chains as effective as local exercise? A randomised-controlled trial. J Sports Sci. 2017 Oct;35(20):2021-2027. doi: 10.1080/02640414.2016.1251606. Epub 2016 Nov 7.
PubMed 27819537

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05353075
Acronym / sponsor ID: REC/Lhr/22/0133 Sumaiya
Conditions: Neck Pain Patients With Hamstring Tightness
Keywords: Hamstring Muscles, Neck Pain, Muscle Tightness, PNF Stretching, Range of Motion
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 25 Apr 2022 (actual)
Primary completion: 25 Dec 2022 (estimated)
Study completion: 10 Jan 2023 (estimated)
First posted: 29 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sub Occipital Muscle Inhibition	Other	Other: Sub Occipital Muscle InhibitionSubjects in this group will receive only Sub Occipital Muscle Inhibition Technique and heating pad for 10 minutes.
Sub Occipital Inhibition with Hold Relax Agonist Contraction	Experimental	Other: Sub Occipital Muscle Inhibition, Other: Sub Occipital Inhibition with Hold Relax Agonist ContractionSubjects in this group will receive Sub Occipital Inhibition and Hold Relax Agonist Contraction of hamstrings.

Who may qualify

Ages: 25 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sub Occipital Muscle InhibitionThe 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, Sub Occipital Muscle Inhibition
Sub Occipital Inhibition with Hold Relax Agonist ContractionTherapist 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.	Other	Sub Occipital Inhibition with Hold Relax Agonist Contraction

Primary outcome

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.
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)
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.
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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
Background: PubMed 28602744Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.
Background: PubMed 31775405Onat 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.
Background: PubMed 27261928Kim 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.
Background: PubMed 25642072Cho SH, Kim SH, Park DJ. The comparison of the immediate effects of application of the suboccipital muscle inhibition and self-myofascial release techniques in the suboccipital region on short hamstring. J Phys Ther Sci. 2015 Jan;27(1):195-7. doi: 10.1589/jpts.27.195. Epub 2015 Jan 9.
Background: PubMed 30248030Jeong ED, Kim CY, Kim SM, Lee SJ, Kim HD. Short-term effects of the suboccipital muscle inhibition technique and cranio-cervical flexion exercise on hamstring flexibility, cranio-vertebral angle, and range of motion of the cervical spine in subjects with neck pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2018;31(6):1025-1034. doi: 10.3233/BMR-171016.
Background: PubMed 34776177Dhiman NR, Das B, Mohanty C, Singh OP, Gyanpuri V, Raj D. Myofascial release versus other soft tissue release techniques along superficial back line structures for improving flexibility in asymptomatic adults: A systematic review with meta-analysis. J Bodyw Mov Ther. 2021 Oct;28:450-457. doi: 10.1016/j.jbmt.2021.06.026. Epub 2021 Jun 16.
Background: PubMed 34639438Kwon 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.
Background: PubMed 34151831Jeong 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.
Background: PubMed 30100320Joshi DG, Balthillaya G, Prabhu A. Effect of remote myofascial release on hamstring flexibility in asymptomatic individuals - A randomized clinical trial. J Bodyw Mov Ther. 2018 Jul;22(3):832-837. doi: 10.1016/j.jbmt.2018.01.008. Epub 2018 Feb 17.
Background: PubMed 27819537Wilke J, Vogt L, Niederer D, Banzer W. Is remote stretching based on myofascial chains as effective as local exercise? A randomised-controlled trial. J Sports Sci. 2017 Oct;35(20):2021-2027. doi: 10.1080/02640414.2016.1251606. Epub 2016 Nov 7.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Saima Zahid, PhD* contact

03334349520

Saima.zahid@riphah.edu.pk

Saima Zahid, PhD* principal investigator

Riphah International University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Saima Zahid, PhD* (03334349520, Saima.zahid@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (NPRS) (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05353075, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.