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Neck PainNCT06108882

Effects of Manual IC With and Without SCS on SCM Tightness With FHP

A study testing Experimental: Manual Ischemic Compression with Strain Counter Strain technique and Active Comparator: Manual Ischemic Compression in people with Neck Pain, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 25 to 40 years
Conditions the study is for
Neck Pain
What is being tested?
Experimental: Manual Ischemic Compression with Strain Counter Strain technique and Active Comparator: Manual Ischemic Compression
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 sitePakistan
Study dates
8 May 2023to 8 Jan 2024
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

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Imran Amjad, Phd contact

03324390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Amina Physiotherapy and Rehab Center, Nusrat Rashid Medical Complex

    Lahore, Punjab Province, 54000

    Saba Rafique, Masters, +923034045433, saba.rafique@riphah.edu.pk

    Maryam Asghar Butt, MS-OMPT

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Manual Ischemic Compression With and Without Strain Counter Strain Technique on Sternocleidomastoid Tightness With Forward Head Posture

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.

Read the 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.

Conditions
Neck Pain
Being tested
Experimental: Manual Ischemic Compression with Strain Counter Strain technique, Active Comparator: Manual Ischemic Compression
Keywords
Disability, Forward head posture, Pain, ROM, Sternocleidomastoid
Medical subject headings
Neck Pain, Pain

What participants receive

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

  • Experimental: Manual Ischemic Compression with Strain Counter Strain techniqueOther

    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.

  • Active Comparator: Manual Ischemic CompressionOther

    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.

Study groups in NCT06108882
Study groupRoleWhat they receive
Manual Ischemic Compression with Strain Counter Strain techniqueExperimentalParticipants in this group will receive Manual Ischemic Compression with Strain Counter Strain technique.
Receives: Other: Experimental: Manual Ischemic Compression with Strain Counter Strain technique
Manual Ischemic CompressionActive comparatorParticipants in this group will receive only Manual Ischemic Compression
Receives: Other: Active Comparator: Manual Ischemic Compression

What is being measured

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

  1. 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.

    Measured: 6 weeks

  2. 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).

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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.

    Measured: 6 weeks

  5. 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. .

    Measured: 6 weeks

  6. Neck ROM

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

    Measured: 6 weeks

Timeline

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

  1. First posted31 Oct 2023
  2. Study start8 May 2023
  3. Primary completion8 Dec 2023 (estimated)
  4. Study completion8 Jan 2024 (estimated)

Resources

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
Participant
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06108882
Sponsor's protocol ID
REC/RCR & AHS/23/0147
Status last verified
Oct 2023
First submitted
25 Oct 2023
Last updated
31 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34870115
  • 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.

    PubMed 33536860
  • 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.

    PubMed 31773477
  • 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.

    PubMed 33083487
  • 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.

    PubMed 31013190
  • 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.

    PubMed 32754534
  • 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.

    PubMed 33612123
  • 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.

    PubMed 35264350
  • 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.

    PubMed 30145129
  • 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.

    PubMed 33090945
  • 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.

    PubMed 37628525
  • 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.

    PubMed 30584118
  • 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.

    PubMed 33897327
  • 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.

    PubMed 28379051
  • 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.

    PubMed 29856244

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Manual Ischemic Compression with Strain Counter Strain technique and Active Comparator: Manual Ischemic Compression in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.

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 3 inclusion and 6 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 31 Oct 2023. 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 Imran Amjad, Phd (03324390125, imran.amjad@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: 6 weeks). The study lists 6 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 NCT06108882, which also lists 28 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 31 Oct 2023.

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