- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06108882
Effects of Manual IC With and Without SCS on SCM Tightness With FHP
Effects of Manual Ischemic Compression With and Without Strain Counter Strain Technique on Sternocleidomastoid Tightness With Forward Head Posture
Study Overview
Status
Conditions
Detailed Description
Forward head posture is defined by excessive extension at upper cervical spine(C1-C3) and flexion at lower cervical spine (C4-C7) that increases cranial rotation angle and decreases craniovertebral angle (CVA) because of the altered relative position of the head with respect to the line of gravity. The bubble inclinometer is a gravity-based tool used to measure the cervical range of motion and to assess SCM muscle length. FHP also leads to muscles imbalance and SCM tightness as well. The Numerical Pain Rating Scale (NPRS) are most frequently used to quantify pain intensity and NDI for neck disability.
A RCT study compare the effects of IC and SCS in patients with upper trapezius trigger points. For four weeks, the therapy was given three days a week. As an outcome indicator, the NPRS, NDI, and cervical lateral flexion were used. The outcome measures were evaluated at baseline, after the second week, and after the fourth week: The ischemic compression and strain counterstrain intervention, which lasted for four weeks, significantly improved cervical range of motion, reduced pain intensity, and reduced cervical disability. However, the intergroup comparison revealed that both interventions were equally effective, and none of them outperformed the others.
Most of the studies compared digital ischemic compression as a common treatment with dry needling or other soft tissue mobilizations specially to treat trapezius trigger points but there are few studies specifically investigating comparative effects of Manual Ischemic Compression with and without Strain Counterstrain for management purpose of muscle tightness in individuals with FHP. While various treatment options exist for FHP, limited research directly compares the comparative outcomes of Strain Counterstrain and Ischemic Compression techniques. Due to lack of comparative evidence regarding the efficacy of these specific interventions, there is a need to bridge this gap by investigating and comparing the effectiveness of these interventions by using highly reliable and valid outcome measures in order to provide healthcare professionals and individuals with evidence-based guidance for optimal FHP management and SCM tightness.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran amjad, phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Recruiting
- Amina Physiotherapy and Rehab Center, Nusrat Rashid Medical Complex
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Contact:
- Saba Rafique, Masters
- Phone Number: +923034045433
- Email: saba.rafique@riphah.edu.pk
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Sub-Investigator:
- Saba Rafique, Masters
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Principal Investigator:
- Maryam Asghar Butt, MS-OMPT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Neck pain (Numeric Pain Rating Scale >3)
- Craniovertebral angle (CVA) less than 51
- Shortened SCM muscle
Exclusion Criteria:
- Neck pain with whiplash or headache, neurological disorder
- History of previous head, neck, cervical spine or shoulder surgery
- Infection or inflammatory arthritis in the cervical spine
History of cervical radiculopathy
- Diagnosed fibromyalgia and myopathy
- History of cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual Ischemic Compression with Strain Counter Strain technique
Participants in this group will receive Manual Ischemic Compression with Strain Counter Strain technique.
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The duration of intervention will be 6 weeks, 3 sessions a week, a total of 18 sessions will be given to the study participants.
Each session will last for 30 to 45 minutes.
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Active Comparator: Manual Ischemic Compression
Participants in this group will receive only Manual Ischemic Compression
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The duration of intervention will be 6 weeks, 3 sessions a week, a total of 18 sessions will be given to the study participants.
Each session will last for 30 to 45 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric pain rating scale (NPRS)
Time Frame: 6 weeks
|
Changes from baseline Numeric pain rating scale is The 11-point scale used to capture the patient's level of pain.
The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.''
Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours.
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6 weeks
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Neck disability index (NDI)
Time Frame: 6 weeks
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Changes from baseline the NDI is a self-report questionnaire with 10 items: Pain intensity, personal care, lifting, work, headaches, concentration, sleeping, driving, reading and recreation.
The response to each item is rated on a six-point scale from 0 (no disability) to 5 (complete disability).
The numeric responses for each item are summed for a total score ranging between 0 and 50; however, some evaluators have chosen to multiply the raw score by 2 and then report the NDI on a 0-100% scale.
Higher scores represent increased levels of related disability among the participants The maximum score is 50.
In which 0 to 4 indicates no disability 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and Above 34 = complete disability(57).
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6 weeks
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The bubble inclinometer
Time Frame: 6 weeks
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Changes from baseline bubble inclinometer is a gravity-based tool used to measure the cervical range of motion and to assess SCM muscle length based on Kendall's description of muscle length testing principles in which the therapist maximally lengthens the muscle from origin to insertion by stabilizing one end, then slowly elongate the muscle, and then assess the end feel.
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6 weeks
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Craniovertebral angle (CVA)
Time Frame: 6 weeks
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Changes from baseline To assess the head position of the subjects, the craniovertebral angle (CVA) was measured.
The craniovertebral angle is identified as the intersection of a horizontal line passing through the C7 spinous process and a line joining the midpoint of the tragus of the ear to the skin overlying the C7 spinous process.
CVA angle less than 51 is considered as FHP.
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6 weeks
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Modified goniometer
Time Frame: 6 weeks
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Changes from baseline the measurement of craniovertebral angle is from C7 spinous process to tragus of ear by modified goniometer.
The craniovertebral angle can be assessed by using modified goniometer to get an accurate estimation of head posture.
The modified goniometer was constructed by attaching a perpendicular rod at the fulcrum of half circle universal goniometer, posteriorly. .
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6 weeks
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Neck ROM
Time Frame: 6 weeks
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Changes from baseline, neck ROM will be taken with the help of goniometer.
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saba Rafique, Masters, Riphah International University
Publications and helpful links
General Publications
- Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.
- Ghan GM, Babu VS. Immediate Effect of Cervico-thoracic Mobilization on Deep Neck Flexors Strength in Individuals with Forward Head Posture: A Randomized Controlled Trial. J Man Manip Ther. 2021 Jun;29(3):147-157. doi: 10.1080/10669817.2020.1834321. Epub 2020 Oct 22.
- Mahmoud NF, Hassan KA, Abdelmajeed SF, Moustafa IM, Silva AG. The Relationship Between Forward Head Posture and Neck Pain: a Systematic Review and Meta-Analysis. Curr Rev Musculoskelet Med. 2019 Dec;12(4):562-577. doi: 10.1007/s12178-019-09594-y.
- Young IA, Dunning J, Butts R, Cleland JA, Fernandez-de-Las-Penas C. Psychometric properties of the Numeric Pain Rating Scale and Neck Disability Index in patients with cervicogenic headache. Cephalalgia. 2019 Jan;39(1):44-51. doi: 10.1177/0333102418772584. Epub 2018 Apr 19.
- Nasb M, Qun X, Ruckmal Withanage C, Lingfeng X, Hong C. Dry Cupping, Ischemic Compression, or Their Combination for the Treatment of Trigger Points: A Pilot Randomized Trial. J Altern Complement Med. 2020 Jan;26(1):44-50. doi: 10.1089/acm.2019.0231. Epub 2019 Oct 3.
- Sikka I, Chawla C, Seth S, Alghadir AH, Khan M. Effects of Deep Cervical Flexor Training on Forward Head Posture, Neck Pain, and Functional Status in Adolescents Using Computer Regularly. Biomed Res Int. 2020 Oct 5;2020:8327565. doi: 10.1155/2020/8327565. eCollection 2020.
- Modarresi S, Lukacs MJ, Ghodrati M, Salim S, MacDermid JC, Walton DM; CATWAD Consortium Group. A Systematic Review and Synthesis of Psychometric Properties of the Numeric Pain Rating Scale and the Visual Analog Scale for Use in People With Neck Pain. Clin J Pain. 2021 Oct 26;38(2):132-148. doi: 10.1097/AJP.0000000000000999.
- Chu ECP, Lo FS, Bhaumik A. Plausible impact of forward head posture on upper cervical spine stability. J Family Med Prim Care. 2020 May 31;9(5):2517-2520. doi: 10.4103/jfmpc.jfmpc_95_20. eCollection 2020 May.
- Kang NY, Im SC, Kim K. Effects of a combination of scapular stabilization and thoracic extension exercises for office workers with forward head posture on the craniovertebral angle, respiration, pain, and disability: A randomized-controlled trial. Turk J Phys Med Rehabil. 2021 Sep 1;67(3):291-299. doi: 10.5606/tftrd.2021.6397. eCollection 2021 Sep.
- Mylonas K, Angelopoulos P, Billis E, Tsepis E, Fousekis K. Combining targeted instrument-assisted soft tissue mobilization applications and neuromuscular exercises can correct forward head posture and improve the functionality of patients with mechanical neck pain: a randomized control study. BMC Musculoskelet Disord. 2021 Feb 21;22(1):212. doi: 10.1186/s12891-021-04080-4. Erratum In: BMC Musculoskelet Disord. 2021 Apr 26;22(1):385.
- Shiravi S, Letafatkar A, Bertozzi L, Pillastrini P, Khaleghi Tazji M. Efficacy of Abdominal Control Feedback and Scapula Stabilization Exercises in Participants With Forward Head, Round Shoulder Postures and Neck Movement Impairment. Sports Health. 2019 May/Jun;11(3):272-279. doi: 10.1177/1941738119835223. Epub 2019 Apr 23.
- Khan A, Khan Z, Bhati P, Hussain ME. Influence of Forward Head Posture on Cervicocephalic Kinesthesia and Electromyographic Activity of Neck Musculature in Asymptomatic Individuals. J Chiropr Med. 2020 Dec;19(4):230-240. doi: 10.1016/j.jcm.2020.07.002. Epub 2020 Nov 24.
- Balthillaya GM, Parsekar SS, Gangavelli R, Prabhu N, Bhat SN, Rao BK. Effectiveness of posture-correction interventions for mechanical neck pain and posture among people with forward head posture: protocol for a systematic review. BMJ Open. 2022 Mar 9;12(3):e054691. doi: 10.1136/bmjopen-2021-054691.
- Ghamkhar L, Kahlaee AH. Is forward head posture relevant to cervical muscles performance and neck pain? A case-control study. Braz J Phys Ther. 2019 Jul-Aug;23(4):346-354. doi: 10.1016/j.bjpt.2018.08.007. Epub 2018 Aug 22.
- Chang MC, Choo YJ, Hong K, Boudier-Reveret M, Yang S. Treatment of Upper Crossed Syndrome: A Narrative Systematic Review. Healthcare (Basel). 2023 Aug 17;11(16):2328. doi: 10.3390/healthcare11162328.
- Cho J, Lee E, Lee S. Upper cervical and upper thoracic spine mobilization versus deep cervical flexors exercise in individuals with forward head posture: A randomized clinical trial investigating their effectiveness. J Back Musculoskelet Rehabil. 2019;32(4):595-602. doi: 10.3233/BMR-181228.
- Alowa Z, Elsayed W. The impact of forward head posture on the electromyographic activity of the spinal muscles. J Taibah Univ Med Sci. 2020 Dec 16;16(2):224-230. doi: 10.1016/j.jtumed.2020.10.021. eCollection 2021 Apr.
- Cibulka MT, Herren J, Kilian A, Smith S, Mahmutovic F, Dolles C. The reliability of assessing sternocleidomastoid muscle length and strength in adults with and without mild neck pain. Physiother Theory Pract. 2017 Apr;33(4):323-330. doi: 10.1080/09593985.2017.1302539. Epub 2017 Apr 5.
- Joshi R, Poojary N. The Effect of Muscle Energy Technique and Posture Correction Exercises on Pain and Function in Patients with Non-specific Chronic Neck Pain Having Forward Head Posture-a Randomized Controlled Trail. Int J Ther Massage Bodywork. 2022 Jun 1;15(2):14-21. doi: 10.3822/ijtmb.v15i2.673. eCollection 2022 Jun.
- Hasuo H, Hashimoto K, Iwamoto H, Miwa N, Kawashima T, Oda A, Sekimoto G. Effect of ischemic compression performed by family caregivers on myofascial pain syndrome and the care burden of the families of patients: a multicenter open-label randomized comparative study. Ann Palliat Med. 2022 Apr;11(4):1179-1190. doi: 10.21037/apm-21-2276. Epub 2021 Dec 6.
- Otadi K, Sarafraz H, Jalaie S, Rasouli O. Combining Patient Education With Dry Needling and Ischemic Compression for Treating Myofascial Trigger Points in Office Workers With Neck Pain: A Single-Blinded, Randomized Trial. J Chiropr Med. 2020 Dec;19(4):222-229. doi: 10.1016/j.jcm.2020.02.005. Epub 2020 Nov 24.
- Fritz K, Krupa K, Carr Jr CL. Physiology, Counterstrain and Facilitated Positional Release (FPR). 2022 Oct 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562152/
- Bazzi MO, Sergent SR. Osteopathic Manipulative Treatment: Counterstrain Procedure - Cervical Vertebrae. 2023 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560846/
- Azam I, Chahal A, Kapoor G, Chaudhuri P, Alghadir AH, Khan M, Kashoo FZ, Esht V, Alshehri MM, Shaphe MA, Khan AR, Singh G. Effects of a program consisting of strain/counterstrain technique, phonophoresis, heat therapy, and stretching in patients with temporomandibular joint dysfunction: A pilot study. Medicine (Baltimore). 2023 Aug 11;102(32):e34569. doi: 10.1097/MD.0000000000034569.
- El-Khateeb YS, Mahmoud AG, Mohamed MH, Abd El-Azeim AS. Influence of adding strain-counterstrain to standard therapy on axioscapular muscles amplitude and fatigue in mechanical neck pain: a single-blind, randomized trial. Eur J Phys Rehabil Med. 2022 Aug;58(4):621-629. doi: 10.23736/S1973-9087.22.07194-5. Epub 2022 Jun 6.
- da Silva AC, De Noronha M, Liberatori-Junior RM, Aily JB, Goncalves GH, Arrais-Lima C, de Araujo Vieira LMSM, Mattiello SM. The Effectiveness of Ischemic Compression Technique on Pain and Function in Individuals With Shoulder Pain: A Systematic Review. J Manipulative Physiol Ther. 2020 Mar-Apr;43(3):234-246. doi: 10.1016/j.jmpt.2019.10.013. Epub 2020 Aug 1.
- Togha M, Bahrpeyma F, Jafari M, Nasiri A. A sonographic comparison of the effect of dry needling and ischemic compression on the active trigger point of the sternocleidomastoid muscle associated with cervicogenic headache: A randomized trial. J Back Musculoskelet Rehabil. 2020;33(5):749-759. doi: 10.3233/BMR-171077.
- Kim SY, An CM, Cha YS, Kim DH. Effects of sling-based manual therapy on cervicothoracic junction in patients with neck pain and forward head posture: A randomized clinical trial. J Bodyw Mov Ther. 2021 Jul;27:447-454. doi: 10.1016/j.jbmt.2021.03.007. Epub 2021 Mar 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0147
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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