NCT06108882

Brief Summary

The aim of this study is to compare the effects of Manual Ischemic Compression with and without Strain Counterstrain technique on CVA, ROM, pain and disability among FHP individuals with SCM tightness.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 25, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

DisabilityForward head posturePainROMSternocleidomastoid

Outcome Measures

Primary Outcomes (6)

  • Numeric pain rating scale (NPRS)

    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.

    6 weeks

  • Neck disability index (NDI)

    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).

    6 weeks

  • The bubble inclinometer

    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.

    6 weeks

  • Craniovertebral angle (CVA)

    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.

    6 weeks

  • Modified goniometer

    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. .

    6 weeks

  • Neck ROM

    Changes from baseline, neck ROM will be taken with the help of goniometer.

    6 weeks

Study Arms (2)

Manual Ischemic Compression with Strain Counter Strain technique

EXPERIMENTAL

Participants in this group will receive Manual Ischemic Compression with Strain Counter Strain technique.

Other: Experimental: Manual Ischemic Compression with Strain Counter Strain technique

Manual Ischemic Compression

ACTIVE COMPARATOR

Participants in this group will receive only Manual Ischemic Compression

Other: Active Comparator: Manual Ischemic Compression

Interventions

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.

Manual Ischemic Compression with Strain Counter Strain technique

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.

Manual Ischemic Compression

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Neck pain (Numeric Pain Rating Scale \>3)
  • Craniovertebral angle (CVA) less than 51
  • Shortened SCM muscle

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amina Physiotherapy and Rehab Center, Nusrat Rashid Medical Complex

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (28)

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    PMID: 34870115BACKGROUND
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    PMID: 31773477BACKGROUND
  • 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.

    PMID: 33083487BACKGROUND
  • 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.

    PMID: 31013190BACKGROUND
  • 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.

    PMID: 32754534BACKGROUND
  • 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.

    PMID: 33612123BACKGROUND
  • 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.

    PMID: 35264350BACKGROUND
  • 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.

    PMID: 30145129BACKGROUND
  • 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.

    PMID: 33090945BACKGROUND
  • 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.

    PMID: 37628525BACKGROUND
  • 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.

    PMID: 30584118BACKGROUND
  • 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.

    PMID: 33897327BACKGROUND
  • 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.

    PMID: 28379051BACKGROUND
  • 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.

    PMID: 29856244BACKGROUND
  • 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.

    PMID: 29673262BACKGROUND
  • 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.

    PMID: 35686175BACKGROUND
  • 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.

    PMID: 31580695BACKGROUND
  • 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.

    PMID: 34894707BACKGROUND
  • 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.

    PMID: 33536859BACKGROUND
  • Fritz K, Krupa KN, Sina RE, Carr Jr CL. Physiology, Counterstrain and Facilitated Positional Release (FPR). 2023 Nov 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562152/

    PMID: 32965823BACKGROUND
  • Bazzi MO, Sergent SR. Osteopathic Manipulative Treatment: Counterstrain Procedure - Cervical Vertebrae. 2023 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560846/

    PMID: 32809681BACKGROUND
  • 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: [corrected]. Medicine (Baltimore). 2023 Aug 11;102(32):e34569. doi: 10.1097/MD.0000000000034569.

    PMID: 37565891BACKGROUND
  • 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.

    PMID: 35666489BACKGROUND
  • 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.

    PMID: 34699406BACKGROUND
  • 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.

    PMID: 32747150BACKGROUND
  • 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.

    PMID: 31815684BACKGROUND
  • 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.

    PMID: 34391270BACKGROUND

MeSH Terms

Conditions

Neck PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Saba Rafique, Masters

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

May 8, 2023

Primary Completion

December 8, 2023

Study Completion

January 8, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations