Erector Spinae TightnessNCT05280977
Effects Of Post Isometric Relaxation And Post Facilitation Stretching On ROM, Pain And Functional Limitations
A study testing POST ISOMETRIC RELAXATION and POST FACILITATION STRETCHING in people with Erector Spinae Tightness, run by University of Lahore at 1 site in Pakistan.
Trial summary
Study Design: Randomized Controlled Trial treatment techniques: post isometric relaxation and post facilitation stretching technique sample size: 35 in each group single blinded Before giving either treatment to each group, baseline data will be collected from each participant and then after 4th week of treatment. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Erector Spinae Tightness
- What is being tested?
- POST ISOMETRIC RELAXATION and POST FACILITATION STRETCHING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Nov 2021to 11 Apr 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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Pain in lower back for atleast 4 weeks but less than 1 year.
- Pain relieved by rest.
- Decreased flexion, extension and lateral flexion of lumbar spine.
- Individuals having no signs of nerve root irritation (dermatomal pain and paresthesia) and nerve root compression (dermatomal sensory loss, myotomal weakness, loss of reflex)
- Age group: 30 - 45 years
- Both male and female
Who cannot join
- Individuals having other lumbar pathologies like disc problems, ligamentous strains, sciatica etc
- Individuals having any inflammation and malignancy.
- Pregnancy
- Individuals having recent trauma, fracture, or surgery
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Bahria International Hospital Lahore
Lahore, Punjab Province, 54590
HAFIZ AMMAR QAYYUM, MSPT, 03126554550, ammarmalik00712@gmail.com
syeda rahat jabeen, MSPT
About this study
Official title: Comparative Effects Of Post Isometric Relaxation And Post Facilitation Stretching On Range Of Motion, Pain And Functional Limitations In Patients With Erector Spinae Tightness: A Randomized Controlled Trial
Study Design: Randomized Controlled Trial treatment techniques: post isometric relaxation and post facilitation stretching technique sample size: 35 in each group single blinded Before giving either treatment to each group, baseline data will be collected from each participant and then after 4th week of treatment.
Read the detailed description
To compare the effects of post isometric relaxation and post facilitation stretching on Rom, pain and functional disability in patients with erector spinae tightness.Study Setting: Bahria International Hospital, Lahore Data will be analyzed using SPSS version 26.The quantitative variables like range of motion will be presented in the form of mean ±SD and qualitative variables like pain and functional disability will be presented in the form of frequency and percentage.
- Conditions
- Erector Spinae Tightness
- Being tested
- POST ISOMETRIC RELAXATION, POST FACILITATION STRETCHING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POST ISOMETRIC RELAXATIONOther
Group A (Post Isometric Relaxation + Conventional Physiotherapy): This group will receive Muscle Energy Technique in addition to conventional physiotherapy for the treatment of erector spinae tightness. The treatment will be given on alternate days for four weeks with 8 - 10 repetitions of METs per session.
POST FACILITATION STRETCHINGOther
Group B (Post Facilitation Stretching + Conventional Physiotherapy):
This group will receive Post Facilitation Stretching Technique in addition to conventional physiotherapy for the treatment of erector spinae tightness. The treatment will be given on alternate days for four weeks with 8 - 10 repetitions of METs per session.
| Study group | Role | What they receive |
|---|---|---|
| POST ISOMETRIC RELAXATION | Experimental | Not described Receives: Other: POST ISOMETRIC RELAXATION |
| POST FACILITATION STRETCHING | Experimental | Not described Receives: Other: POST FACILITATION STRETCHING |
What is being measured
The primary outcome is the main question the study is designed to answer.
goniometer
Range of motion will be measured by using universal standard goniometer.The goniometer comprises a body (rotation axis) with two arms attached to it, one being fixed and the other movable. The measurement of the ROM is performed by direct reading of the angle between the axis of rotation at the end of the active ROM of the movement assessed.
Measured: 4 WEEKS
Secondary outcomes (1)
visual analog scale
The Visual Analogue Scale (VAS) is an instrument for the measurement of subjective characteristics or attitudes that cannot be measured directly. It consists of a horizontal line with markings from 0 - 10 where "0" represents "no pain" and "10" represents "worst pain possible". The patient is asked to mark the number on the scale which best describes the level of his/her pain.
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 posted15 Mar 2022
- Study start3 Nov 2021
- Primary completion2 Apr 2022 (estimated)
- Study completion11 Apr 2022 (estimated)
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 Erector Spinae TightnessStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SYEDA RAHAT JABEEN, MSPT, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280977
- Sponsor's protocol ID
- IRB-UOL-FAHS/1027/2021
- Status last verified
- Mar 2022
- First submitted
- 5 Mar 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
PubMed 21982256Bogduk N. Functional anatomy of the spine. Handb Clin Neurol. 2016;136:675-88. doi: 10.1016/B978-0-444-53486-6.00032-6.
PubMed 27430435Panjabi MM, Goel V, Oxland T, Takata K, Duranceau J, Krag M, Price M. Human lumbar vertebrae. Quantitative three-dimensional anatomy. Spine (Phila Pa 1976). 1992 Mar;17(3):299-306. doi: 10.1097/00007632-199203000-00010.
PubMed 1566168Sung PS, Lammers AR, Danial P. Different parts of erector spinae muscle fatigability in subjects with and without low back pain. Spine J. 2009 Feb;9(2):115-20. doi: 10.1016/j.spinee.2007.11.011. Epub 2008 Feb 14.
PubMed 18280212Friberg O. Clinical symptoms and biomechanics of lumbar spine and hip joint in leg length inequality. Spine (Phila Pa 1976). 1983 Sep;8(6):643-51. doi: 10.1097/00007632-198309000-00010.
PubMed 6228021Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, Baciarello M, Manferdini ME, Fanelli G. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.
PubMed 27408698Wilson E, Payton O, Donegan-Shoaf L, Dec K. Muscle energy technique in patients with acute low back pain: a pilot clinical trial. J Orthop Sports Phys Ther. 2003 Sep;33(9):502-12. doi: 10.2519/jospt.2003.33.9.502.
PubMed 14524509
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of Post Isometric Relaxation And Post Facilitation Stretching On Range Of Motion, Pain And Functional Limitations In Patients With Erector Spinae Tightness: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05280977
- Acronym / sponsor ID
- IRB-UOL-FAHS/1027/2021
- Conditions
- Erector Spinae Tightness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 2 Apr 2022 (estimated)
- Study completion
- 11 Apr 2022 (estimated)
- First posted
- 15 Mar 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.
Study Design: Randomized Controlled Trial treatment techniques: post isometric relaxation and post facilitation stretching technique sample size: 35 in each group single blinded Before giving either treatment to each group, baseline data will be collected from each participant and then after 4th week of treatment.
Detailed description
To compare the effects of post isometric relaxation and post facilitation stretching on Rom, pain and functional disability in patients with erector spinae tightness.Study Setting: Bahria International Hospital, Lahore Data will be analyzed using SPSS version 26.The quantitative variables like range of motion will be presented in the form of mean ±SD and qualitative variables like pain and functional disability will be presented in the form of frequency and percentage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POST ISOMETRIC RELAXATION | Experimental | Other: POST ISOMETRIC RELAXATION |
| POST FACILITATION STRETCHING | Experimental | Other: POST FACILITATION STRETCHING |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Pain in lower back for atleast 4 weeks but less than 1 year.
Key exclusion criteria (4 listed)
- Individuals having other lumbar pathologies like disc problems, ligamentous strains, sciatica etc
- Individuals having any inflammation and malignancy.
- Pregnancy
- Individuals having recent trauma, fracture, or surgery
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 |
|---|---|---|
| POST ISOMETRIC RELAXATIONGroup A (Post Isometric Relaxation + Conventional Physiotherapy): This group will receive Muscle Energy Technique in addition to conventional physiotherapy for the treatment of erector spinae tightness. The treatment will be given on alternate days for four weeks with 8 - 10 repetitions of METs per session. | Other | POST ISOMETRIC RELAXATION |
| POST FACILITATION STRETCHINGGroup B (Post Facilitation Stretching + Conventional Physiotherapy): This group will receive Post Facilitation Stretching Technique in addition to conventional physiotherapy for the treatment of erector spinae tightness. The treatment will be given on alternate days for four weeks with 8 - 10 repetitions of METs per session. | Other | POST FACILITATION STRETCHING |
Primary outcome
goniometer
Time frame: 4 WEEKS
Range of motion will be measured by using universal standard goniometer.The goniometer comprises a body (rotation axis) with two arms attached to it, one being fixed and the other movable. The measurement of the ROM is performed by direct reading of the angle between the axis of rotation at the end of the active ROM of the movement assessed.
1 secondary outcome
visual analog scale
Time frame: 4 WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Background: PubMed 21982256Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- Background: PubMed 27430435Bogduk N. Functional anatomy of the spine. Handb Clin Neurol. 2016;136:675-88. doi: 10.1016/B978-0-444-53486-6.00032-6.
- Background: PubMed 1566168Panjabi MM, Goel V, Oxland T, Takata K, Duranceau J, Krag M, Price M. Human lumbar vertebrae. Quantitative three-dimensional anatomy. Spine (Phila Pa 1976). 1992 Mar;17(3):299-306. doi: 10.1097/00007632-199203000-00010.
- Background: PubMed 18280212Sung PS, Lammers AR, Danial P. Different parts of erector spinae muscle fatigability in subjects with and without low back pain. Spine J. 2009 Feb;9(2):115-20. doi: 10.1016/j.spinee.2007.11.011. Epub 2008 Feb 14.
- Background: PubMed 6228021Friberg O. Clinical symptoms and biomechanics of lumbar spine and hip joint in leg length inequality. Spine (Phila Pa 1976). 1983 Sep;8(6):643-51. doi: 10.1097/00007632-198309000-00010.
- Background: PubMed 27408698Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, Baciarello M, Manferdini ME, Fanelli G. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.
- Background: PubMed 14524509Wilson E, Payton O, Donegan-Shoaf L, Dec K. Muscle energy technique in patients with acute low back pain: a pilot clinical trial. J Orthop Sports Phys Ther. 2003 Sep;33(9):502-12. doi: 10.2519/jospt.2003.33.9.502.
- Individual participant dataSharing planned: No
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.
SYEDA RAHAT JABEEN, MSPT 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 POST ISOMETRIC RELAXATION and POST FACILITATION STRETCHING in people with Erector Spinae Tightness, 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 6 inclusion and 4 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 15 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiderullah khan, MS PTN (0092314127210, haiderullah@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
goniometer (time frame: 4 WEEKS). 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 NCT05280977, 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 15 Mar 2022.