Cross SyndromeNCT04668040
Comparison of Stretching and MET in Lower Cross Syndrome
A study testing Muscle energy technique and Stretching in people with Cross Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the study is to compare the effects of stretching exercises \& muscle energy techniques in the management of lower cross syndrome and to find the effective treatment in the lower cross syndrome management. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Cross Syndrome
- What is being tested?
- Muscle energy technique and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2018to 20 Dec 2018
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- LCS pattern in standing position
- Patients having Chronic low back pain
- Age : 20-50 years
- Both male and females
- Positive Prone Hip Extension movement pattern test
Who cannot join
- Fracture (wedge compression #)
- Inflammatory disorder
- Acute disc bulge
- Lumber instability
- Idiopathic scoliosis
- Patient with Rheumatoid arthritis (RA) and other systemic diseases
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bibi Zahida Memorial Teaching Hospital NCS
Peshawar, KPK, 25000
About this study
Official title: Comparing the Effects of Stretching and Muscle Energy Technique in the Management of Lower Cross Syndrome
The aim of the study is to compare the effects of stretching exercises \& muscle energy techniques in the management of lower cross syndrome and to find the effective treatment in the lower cross syndrome management.
Read the detailed description
In 2015 the systematic review estimated that prevalence of Chronic low back pain in 24 to 39 year old individual was 4.2% and the individual between 20 to 59 was 19.6% . The genesis and perpetuation of Low back pain (LBP) has many underlying factors among which one is proposed by Janda's concept of pelvic crossed syndrome. This condition describes a pattern of tight and weak muscles around the pelvis. Marked postural deviation is seen such as increased lumber lordosis and depending on this lordosis the muscle involvement can be distinguished. The center of the gravity is slightly anterior to S1 or S2, which means pelvis position, is key to faulty or good alignment.
Various studies have been done on muscle imbalance Lower crossed syndrome (LCS) using Stretching and Muscle energy Technique (MET). Both have shown superior effects when compared to other treatment modalities/techniques. However there is paucity of literature on effectiveness of stretching and MET in management of LCS.
- Conditions
- Cross Syndrome
- Being tested
- Muscle energy technique, Stretching
- Keywords
- Muscle energy technique, Lower cross syndrome, stretching
- 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
Muscle energy technique for illiopsoas, rectus femoris, erector spinae \& hamstrings muscles duration of contraction was 10 sec, rest interval was 5 sec, stretch duration was 30 sec, number of repetition of stretch was 5, number of set was 1, frequency per week was 3
StretchingOther
Stretching exercises for illiopsoas, rectus femoris, erector spinae \& hamstrings muscles duration of stretch was 15 sec, rest interval was 5 sec, number of repetition was 5, number of set was 1, frequency per week was 3
| Study group | Role | What they receive |
|---|---|---|
| Muscle energy technique | Experimental | Muscle energy technique applied in the lower cross syndrome muscle pattern. Receives: Other: Muscle energy technique |
| Stretching | Active comparator | Stretching technique applied in the lower cross syndrome muscle pattern. Receives: Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
It was calculated through Numeric pain rating scale (NPRS) in which 0 was the lowest value with no pain label and 10 was the highest value with worst possible pain label. The Subjects with respect to their pain intensity were asked to mark a level of NPRS.
Measured: 4th week
ROM assessment of iliopsoas
Range of motion (ROM) was taken via goniometer for iliopsoas was measured with double inclinometer.
Measured: 4th week
ROM assessment of rectus femoris
Range of motion (ROM) was taken via goniometer for rectus femoris was measured with double inclinometer.
Measured: 4th week
ROM assessment of hamstrings
Range of motion (ROM) was taken via goniometer for hamstrings was measured with double inclinometer.
Measured: 4th week
ROM assessment of erector spinae
Range of motion (ROM) was taken via goniometer for erector spinae was measured with double inclinometer.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Jul 2018
- Primary completion1 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cross SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Affan Iqbal, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668040
- Sponsor's protocol ID
- REC/00383 Nouman Khan
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frank C, Page P, Lardner R. Assessment and treatment of muscle imbalance: the Janda approach: Human kinetics; 2009.
Key J, Clift A, Condie F, Harley C. A model of movement dysfunction provides a classification system guiding diagnosis and therapeutic care in spinal pain and related musculoskeletal syndromes: a paradigm shift-Part 1. J Bodyw Mov Ther. 2008 Jan;12(1):7-21. doi: 10.1016/j.jbmt.2007.04.005. Epub 2007 Jun 11.
PubMed 19083651Kolar P. Facilitation of agonist-antagonist co-activation by reflex stimulation methods. Rehabilitation of the Spine. 2007:531-65.
Norkin CC, White DJ. Measurement of joint motion: a guide to goniometry, 5th edition: FA Davis; 2016.
Kage MV. Effectiveness of Stretching and Strengthening Exercises in Patients with postural Low Back Pain A Randomized Controlled Trial. 2017.
Abutaleb EE, Eldesoky MT, El Rasol SA. Effect of Muscle Energy Technique on Anterior Pelvic Tilt in Lumbar Spondylosis Patients. World Academy of Science, Engineering and Technology, International Journal of Medical, Health, Biomedical, Bioengineering and Pharmaceutical Engineering. 2015;9(8):651-5.
Ahmed ET, Abdelkarim SS. Efficacy of muscle energy technique versus static stretching technique in increasing hamstring flexibility post burn contracture. Int J Health Rehabil Sci. 2013;2(1):22-7.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Stretching and Muscle Energy Technique in the Management of Lower Cross Syndrome
- ClinicalTrials.gov ID
- NCT04668040
- Acronym / sponsor ID
- REC/00383 Nouman Khan
- Conditions
- Cross Syndrome
- Keywords
- Muscle energy technique, Lower cross syndrome, stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 16 Dec 2020 (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 aim of the study is to compare the effects of stretching exercises \& muscle energy techniques in the management of lower cross syndrome and to find the effective treatment in the lower cross syndrome management.
Detailed description
In 2015 the systematic review estimated that prevalence of Chronic low back pain in 24 to 39 year old individual was 4.2% and the individual between 20 to 59 was 19.6% . The genesis and perpetuation of Low back pain (LBP) has many underlying factors among which one is proposed by Janda's concept of pelvic crossed syndrome. This condition describes a pattern of tight and weak muscles around the pelvis. Marked postural deviation is seen such as increased lumber lordosis and depending on this lordosis the muscle involvement can be distinguished. The center of the gravity is slightly anterior to S1 or S2, which means pelvis position, is key to faulty or good alignment.
Various studies have been done on muscle imbalance Lower crossed syndrome (LCS) using Stretching and Muscle energy Technique (MET). Both have shown superior effects when compared to other treatment modalities/techniques. However there is paucity of literature on effectiveness of stretching and MET in management of LCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle energy technique | Experimental | Other: Muscle energy techniqueMuscle energy technique applied in the lower cross syndrome muscle pattern. |
| Stretching | Active comparator | Other: StretchingStretching technique applied in the lower cross syndrome muscle pattern. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- LCS pattern in standing position
- Patients having Chronic low back pain
- Age : 20-50 years
- Both male and females
- Positive Prone Hip Extension movement pattern test
Key exclusion criteria (6 listed)
- Fracture (wedge compression #)
- Inflammatory disorder
- Acute disc bulge
- Lumber instability
- Idiopathic scoliosis
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 techniqueMuscle energy technique for illiopsoas, rectus femoris, erector spinae \& hamstrings muscles duration of contraction was 10 sec, rest interval was 5 sec, stretch duration was 30 sec, number of repetition of stretch was 5, number of set was 1, frequency per week was 3 | Other | Muscle energy technique |
| StretchingStretching exercises for illiopsoas, rectus femoris, erector spinae \& hamstrings muscles duration of stretch was 15 sec, rest interval was 5 sec, number of repetition was 5, number of set was 1, frequency per week was 3 | Other | Stretching |
Primary outcome
Numeric pain rating scale
Time frame: 4th week
It was calculated through Numeric pain rating scale (NPRS) in which 0 was the lowest value with no pain label and 10 was the highest value with worst possible pain label. The Subjects with respect to their pain intensity were asked to mark a level of NPRS.
ROM assessment of iliopsoas
Time frame: 4th week
Range of motion (ROM) was taken via goniometer for iliopsoas was measured with double inclinometer.
ROM assessment of rectus femoris
Time frame: 4th week
Range of motion (ROM) was taken via goniometer for rectus femoris was measured with double inclinometer.
ROM assessment of hamstrings
Time frame: 4th week
Range of motion (ROM) was taken via goniometer for hamstrings was measured with double inclinometer.
ROM assessment of erector spinae
Time frame: 4th week
Range of motion (ROM) was taken via goniometer for erector spinae was measured with double inclinometer.
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 16 Dec 2020.
- BackgroundFrank C, Page P, Lardner R. Assessment and treatment of muscle imbalance: the Janda approach: Human kinetics; 2009.
- Background: PubMed 19083651Key J, Clift A, Condie F, Harley C. A model of movement dysfunction provides a classification system guiding diagnosis and therapeutic care in spinal pain and related musculoskeletal syndromes: a paradigm shift-Part 1. J Bodyw Mov Ther. 2008 Jan;12(1):7-21. doi: 10.1016/j.jbmt.2007.04.005. Epub 2007 Jun 11.
- BackgroundKolar P. Facilitation of agonist-antagonist co-activation by reflex stimulation methods. Rehabilitation of the Spine. 2007:531-65.
- BackgroundNorkin CC, White DJ. Measurement of joint motion: a guide to goniometry, 5th edition: FA Davis; 2016.
- BackgroundKage MV. Effectiveness of Stretching and Strengthening Exercises in Patients with postural Low Back Pain A Randomized Controlled Trial. 2017.
- BackgroundAbutaleb EE, Eldesoky MT, El Rasol SA. Effect of Muscle Energy Technique on Anterior Pelvic Tilt in Lumbar Spondylosis Patients. World Academy of Science, Engineering and Technology, International Journal of Medical, Health, Biomedical, Bioengineering and Pharmaceutical Engineering. 2015;9(8):651-5.
- BackgroundAhmed ET, Abdelkarim SS. Efficacy of muscle energy technique versus static stretching technique in increasing hamstring flexibility post burn contracture. Int J Health Rehabil Sci. 2013;2(1):22-7.
- 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.
Muhammad Affan Iqbal, 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?
A study testing Muscle energy technique and Stretching in people with Cross Syndrome, 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 5 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: finished, as of the sponsor's last update on 16 Dec 2020. 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: 4th week). The study lists 5 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 NCT04668040, which also lists 7 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 Dec 2020.