Upper Cross SyndromeNCT05190328
Muscle Energy Technique Versus Active Release Technique on Pain, Cervical Range Of Motion And Functional Disability
A study testing Muscle Energy Technique and Active Release Technique in people with Upper Cross Syndrome, run by University of Lahore at 1 site in Pakistan.
Trial summary
The study will be a randomized controlled trial. This study will be conducted in The University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 86 will be randomly allocated into two experimental groups,(43 participants in each group), by using computer-generated random number list method. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Upper Cross Syndrome
- What is being tested?
- Muscle Energy Technique and Active Release Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Nov 2021to 1 Jul 2022
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • The diagnosed Upper cross syndrome patients aged 20-35 years will be included in this study
- Both male and females will be included in this study.
- Patients with pain of at least 3 points on NPRS.
- The participants with neck disability of at least 10/50 on the Neck Disability Index (NDI) will be included in this study.
Who cannot join
- • Cervical radiculopathy or myelopathy.
- History of trauma, whiplash injury, cervical instability or fractures in cervical spine.
- Systemic illness i.e. cardiovascular disorders, respiratory disorders etc.
- Inflammatory disease i.e. rheumatoid arthritis, ankylosing spondylitis, osteomyelitis.
- Any pathology i.e. infection, osteoporosis, malignancy bony disease i.e. osteosarcoma.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province, 55150
About this study
Official title: Effects Of Muscle Energy Technique Versus Active Release Technique On Pain, Cervical Range Of Motion And Functional Disability In Patients With Upper Cross Syndrome: A Randomized Controlled Trial.
The study will be a randomized controlled trial. This study will be conducted in The University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 86 will be randomly allocated into two experimental groups,(43 participants in each group), by using computer-generated random number list method. The participants randomly allocated into two experimental, group A will receive Muscle energy technique (METs) specifically, Post isometric relaxation technique for upper trapezius and levator scapulae muscles, 1 set of 5 repetitions and 10 seconds hold along with routine physical therapy as (Hot pack, transcutaneous electrical nerve stimulator, strengthening and stretching exercises).
Experimental group B will be delivered Active Release Technique on both sides of levator scapulae and upper trapezius muscles 1 set of 5 repetitions along with routine physical therapy as (Hot pack, transcutaneous electrical nerve stimulator, strengthening and stretching exercises).
Both experimental groups will receive twelve treatment sessions (3 sessions per week for 4 weeks)
Read the detailed description
Recruitment: Participants will be recruited and referred by orthopedic doctor from The University of Lahore Teaching Hospital to Physical Therapy Department.
Randomization and Allocation: The participants after confirming the eligibility criteria will be randomly allocated into two experimental groups (Group A, Group B) by using computer generated random number list method.
Blindness: The study will be single blinded, and an independent investigator will perform randomization and will inform the patients and the therapist about the allocation of participants and assessor will be blinded.
Intervention: The participants will be randomly allocated into two experimental groups (Group A, Group B). Experimental Group A will receive Muscle energy technique (METs) specifically, Post isometric relaxation technique for upper trapezius and levator scapulae muscles, 1 set of 5 repetitions, and 10 seconds hold along with routine physical therapy as (Hot pack, transcutaneous electrical nerve stimulator, strengthening and stretching exercises).
Experimental group B will be delivered Active Release Technique on both sides of levator scapulae and upper trapezius muscles 1 set of 5 repetitions along with routine physical therapy as (Hot pack, TENS, strengthening and stretching exercises).
Duration:Both experimental groups will receive twelve treatment sessions (3 sessions per week for 4 weeks, each session of 35-45 minutes)
Outcome Variables and Measures:
Pain (Numeric Pain Rating Scale) Range of Motion (Universal Goniometer) Functional Disability (Neck disability Index Questionnaire) Outcome measures will be taken at baseline, end of 6th treatment session (2nd week), end of 12th session (4th week) and follow up will be obtained after 1 month (8th week) and then collected data will be analyzed.
- Conditions
- Upper Cross Syndrome
- Being tested
- Muscle Energy Technique, Active Release Technique
- Keywords
- Upper Cross Syndrome
- Medical subject headings
- Oculocerebral hypopigmentation syndrome type Preus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy TechniqueOther
Experimental: Muscle Energy Technique Post isometric relaxation: Patient will perform isometrics on upper trapezius and levator scapulae one by one. Each isometric contraction will be held for 10 seconds and then participants will be asked to relax the contraction with exhalation. This will be repeated five times in one session.
Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with Muscle energy technique.
Active Release TechniqueOther
Experimental: Active Release Technique: Therapist will apply deep pressure on both sides of levator scapulae and upper trapezius muscles (over the area of tenderness) and the patient is instructed to actively move the muscle from the shortened to a lengthened position and thereby breaking adhesions. 1 set of 5 repetitions in one session.
Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with Active Release Technique.
| Study group | Role | What they receive |
|---|---|---|
| Muscle Energy Technique | Experimental | Experimental: Muscle Energy Technique Post isometric relaxation: Patient will perform isometrics on upper trapezius and levator scapulae one by one. Each isometric contraction will be held for 10 seconds and then participants will be asked to relax the contraction with exhalation. This will be repeated five times in one session.
Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with the Muscle energy technique. Receives: Other: Muscle Energy Technique |
| Active Release Technique | Experimental | Experimental: Active Release Technique: The therapist will apply deep pressure on both sides of levator scapulae and upper trapezius muscles (over the area of tenderness) and the patient will be instructed to actively move the muscle from a shortened to lengthened position and thereby breaking adhesions.1 set of 5 repetitions in one session.
Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with active release technique Receives: Other: Active Release Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numeric pain rating scale (NPRS) is self-reported and simple tool to measure level of pain. This is 11-point numeric scale in this scale the respondents will select the intensity of their pain ranging from 0-10, where 0 means no pain and 10 means severe pain
Measured: 4 weeks
Neck Disability Index (NDI) questionnaire
The neck disability index (NDI) questionnaire is comprise of 10 items and is frequently used as a patient reported outcome measurement tool to evaluate the physical and functional capacity of an individual with cervical pain.Neck disability index is also used to evaluate the difference between pre and post treatment. Each section on NDI is scored on 0 to 5 rating in which 0 points or 0% means no pain or no activity limitation and 5 means worst imaginable pain or 50 points or 100% means complete activity limitation.
Measured: 4 weeks
Range of motion
Universal Goniometer is a clinical and easily available tool which is commonly used by physiotherapist to document the available range of movement at certain joints.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start10 Nov 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Upper Cross SyndromeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anam Akram, University of Lahore
- Investigators
- Anam Akram, MS-MSK*, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190328
- Sponsor's protocol ID
- IRB-UOL-FAHS/980/2021
- Status last verified
- Sep 2022
- First submitted
- 30 Dec 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karimian R, Rahnama N, Ghasemi G, Lenjannejadian S. Photogrammetric Analysis of Upper Cross Syndrome among Teachers and the Effects of National Academy of Sports Medicine Exercises with Ergonomic Intervention on the Syndrome. J Res Health Sci. 2019 Jul 3;19(3):e00450.
PubMed 31586371Kang JI, Choi HH, Jeong DK, Choi H, Moon YJ, Park JS. Effect of scapular stabilization exercise on neck alignment and muscle activity in patients with forward head posture. J Phys Ther Sci. 2018 Jun;30(6):804-808. doi: 10.1589/jpts.30.804. Epub 2018 Jun 12.
PubMed 29950768Kim JH, Lee HS, Park SW. Effects of the active release technique on pain and range of motion of patients with chronic neck pain. J Phys Ther Sci. 2015 Aug;27(8):2461-4. doi: 10.1589/jpts.27.2461. Epub 2015 Aug 21.
PubMed 26357426Thomas E, Cavallaro AR, Mani D, Bianco A, Palma A. The efficacy of muscle energy techniques in symptomatic and asymptomatic subjects: a systematic review. Chiropr Man Therap. 2019 Aug 27;27:35. doi: 10.1186/s12998-019-0258-7. eCollection 2019.
PubMed 31462989Gillani SN, Ain Q-, Rehman SU, Masood T. Effects of eccentric muscle energy technique versus static stretching exercises in the management of cervical dysfunction in upper cross syndrome: a randomized control trial. J Pak Med Assoc. 2020 Mar;70(3):394-398. doi: 10.5455/JPMA.300417.
PubMed 32207413
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Muscle Energy Technique Versus Active Release Technique On Pain, Cervical Range Of Motion And Functional Disability In Patients With Upper Cross Syndrome: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05190328
- Acronym / sponsor ID
- IRB-UOL-FAHS/980/2021
- Conditions
- Upper Cross Syndrome
- Keywords
- Upper Cross Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 13 Jan 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.
The study will be a randomized controlled trial. This study will be conducted in The University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 86 will be randomly allocated into two experimental groups,(43 participants in each group), by using computer-generated random number list method. The participants randomly allocated into two experimental, group A will receive Muscle energy technique (METs) specifically, Post isometric relaxation technique for upper trapezius and levator scapulae muscles, 1 set of 5 repetitions and 10 seconds hold along with routine physical therapy as (Hot pack, transcutaneous electrical nerve stimulator, strengthening and stretching exercises).
Experimental group B will be delivered Active Release Technique on both sides of levator scapulae and upper trapezius muscles 1 set of 5 repetitions along with routine physical therapy as (Hot pack, transcutaneous electrical nerve stimulator, strengthening and stretching exercises).
Both experimental groups will receive twelve treatment sessions (3 sessions per week for 4 weeks)
Detailed description
Recruitment: Participants will be recruited and referred by orthopedic doctor from The University of Lahore Teaching Hospital to Physical Therapy Department.
Randomization and Allocation: The participants after confirming the eligibility criteria will be randomly allocated into two experimental groups (Group A, Group B) by using computer generated random number list method.
Blindness: The study will be single blinded, and an independent investigator will perform randomization and will inform the patients and the therapist about the allocation of participants and assessor will be blinded.
Intervention: The participants will be randomly allocated into two experimental groups (Group A, Group B). Experimental Group A will receive Muscle energy technique (METs) specifically, Post isometric relaxation technique for upper trapezius and levator scapulae muscles, 1 set of 5 repetitions, and 10 seconds hold along with routine physical therapy as (Hot pack, transcutaneous electrical nerve stimulator, strengthening and stretching exercises).
Experimental group B will be delivered Active Release Technique on both sides of levator scapulae and upper trapezius muscles 1 set of 5 repetitions along with routine physical therapy as (Hot pack, TENS, strengthening and stretching exercises).
Duration:Both experimental groups will receive twelve treatment sessions (3 sessions per week for 4 weeks, each session of 35-45 minutes)
Outcome Variables and Measures:
Pain (Numeric Pain Rating Scale) Range of Motion (Universal Goniometer) Functional Disability (Neck disability Index Questionnaire) Outcome measures will be taken at baseline, end of 6th treatment session (2nd week), end of 12th session (4th week) and follow up will be obtained after 1 month (8th week) and then collected data will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle Energy Technique | Experimental | Other: Muscle Energy TechniqueExperimental: Muscle Energy Technique Post isometric relaxation: Patient will perform isometrics on upper trapezius and levator scapulae one by one. Each isometric contraction will be held for 10 seconds and then participants will be asked to relax the contraction with exhalation. This will be repeated five times in one session. Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with the Muscle energy technique. |
| Active Release Technique | Experimental | Other: Active Release TechniqueExperimental: Active Release Technique: The therapist will apply deep pressure on both sides of levator scapulae and upper trapezius muscles (over the area of tenderness) and the patient will be instructed to actively move the muscle from a shortened to lengthened position and thereby breaking adhesions.1 set of 5 repetitions in one session. Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with active release technique |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • The diagnosed Upper cross syndrome patients aged 20-35 years will be included in this study
Key exclusion criteria (5 listed)
- • Cervical radiculopathy or myelopathy.
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 |
|---|---|---|
| Muscle Energy TechniqueExperimental: Muscle Energy Technique Post isometric relaxation: Patient will perform isometrics on upper trapezius and levator scapulae one by one. Each isometric contraction will be held for 10 seconds and then participants will be asked to relax the contraction with exhalation. This will be repeated five times in one session. Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with Muscle energy technique. | Other | Muscle Energy Technique |
| Active Release TechniqueExperimental: Active Release Technique: Therapist will apply deep pressure on both sides of levator scapulae and upper trapezius muscles (over the area of tenderness) and the patient is instructed to actively move the muscle from the shortened to a lengthened position and thereby breaking adhesions. 1 set of 5 repetitions in one session. Routine Physical Therapy including TENS, Hot Pack, Strengthening, and stretching exercises will also be delivered along with Active Release Technique. | Other | Active Release Technique |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 weeks
The Numeric pain rating scale (NPRS) is self-reported and simple tool to measure level of pain. This is 11-point numeric scale in this scale the respondents will select the intensity of their pain ranging from 0-10, where 0 means no pain and 10 means severe pain
Neck Disability Index (NDI) questionnaire
Time frame: 4 weeks
The neck disability index (NDI) questionnaire is comprise of 10 items and is frequently used as a patient reported outcome measurement tool to evaluate the physical and functional capacity of an individual with cervical pain.Neck disability index is also used to evaluate the difference between pre and post treatment. Each section on NDI is scored on 0 to 5 rating in which 0 points or 0% means no pain or no activity limitation and 5 means worst imaginable pain or 50 points or 100% means complete activity limitation.
Range of motion
Time frame: 4 weeks
Universal Goniometer is a clinical and easily available tool which is commonly used by physiotherapist to document the available range of movement at certain joints.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Background: PubMed 31586371Karimian R, Rahnama N, Ghasemi G, Lenjannejadian S. Photogrammetric Analysis of Upper Cross Syndrome among Teachers and the Effects of National Academy of Sports Medicine Exercises with Ergonomic Intervention on the Syndrome. J Res Health Sci. 2019 Jul 3;19(3):e00450.
- Background: PubMed 29950768Kang JI, Choi HH, Jeong DK, Choi H, Moon YJ, Park JS. Effect of scapular stabilization exercise on neck alignment and muscle activity in patients with forward head posture. J Phys Ther Sci. 2018 Jun;30(6):804-808. doi: 10.1589/jpts.30.804. Epub 2018 Jun 12.
- Background: PubMed 26357426Kim JH, Lee HS, Park SW. Effects of the active release technique on pain and range of motion of patients with chronic neck pain. J Phys Ther Sci. 2015 Aug;27(8):2461-4. doi: 10.1589/jpts.27.2461. Epub 2015 Aug 21.
- Background: PubMed 31462989Thomas E, Cavallaro AR, Mani D, Bianco A, Palma A. The efficacy of muscle energy techniques in symptomatic and asymptomatic subjects: a systematic review. Chiropr Man Therap. 2019 Aug 27;27:35. doi: 10.1186/s12998-019-0258-7. eCollection 2019.
- Background: PubMed 32207413Gillani SN, Ain Q-, Rehman SU, Masood T. Effects of eccentric muscle energy technique versus static stretching exercises in the management of cervical dysfunction in upper cross syndrome: a randomized control trial. J Pak Med Assoc. 2020 Mar;70(3):394-398. doi: 10.5455/JPMA.300417.
- Individual participant dataSharing planned: No
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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.
Anam Akram, MS-MSK* principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Energy Technique and Active Release Technique in people with Upper Cross Syndrome, run by University of Lahore 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 4 weeks). The study lists 3 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 NCT05190328, which also lists 5 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 30 Sep 2022.