Low Back Pain, MechanicalNCT06108661
Effects of ELDOA and Slump Stretching on Mechanical Low Back Pain
A study testing Conventional Physical Therapy, Slump Stretching and ELDOA in people with Low Back Pain, Mechanical, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
The title of this study is Shirt term effects of ELDOA and slump steyching in mechanical low back pain. Previous studies have identified the effects of ELDOA and slump stretching on mechanical low back pain, but their short term effects have not been compared. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Conventional Physical Therapy, Slump Stretching and ELDOA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Mar 2023to 15 Dec 2023
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group: 18-45 years old
- Both males and females
- Patients with pain intensity of at least 5 on NPRS
- Positive slump test
Who cannot join
- Any congenital deformities
- Demonstrated neurological deficit
- Pregnant females
- History of spinal surgery
- Spondylolisthesis
- Severe lumbar spondylosis
Show all 11Show fewer
- Spinal stenosis
- Disc herniation
- Serious spinal conditions like infection, tumors, osteoporosis, spinal fracture
- Limb length discrepancy
- Sacroiliac and hip disorder
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Warda Qazi, PPT,PHD*, 03212042129, Warda.qazi@fui.edi.pk
About this study
The title of this study is Shirt term effects of ELDOA and slump steyching in mechanical low back pain. Previous studies have identified the effects of ELDOA and slump stretching on mechanical low back pain, but their short term effects have not been compared. This study will focus on the comparison of these techniques and their effectiveness in patients with mechanical low back pain. The purpose of this study is to compare the short term effects of ELDOA and slump stretching on spatiotemporal gait parameters, lumbar ROM and pain in patients with mechanical low back pain.
Spatiotemporal gait parameters will be measured by using formulas. Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will be allocated to either of the groups through a sealed opaque envelope method. ELODA and slump stretching will be given to groups A and B respectively, along with conventional physical therapy treatment. Inclinometer, NPRS and formulas for spatiotemporal gait parameters will be used as outcome measures.
Read the detailed description
Low back pain is one of the most prevalent musculoskeletal conditions worldwide. Amongst the general population, more than 70% of the people experience low back pain at some time in their lifetime. The prevalence of low back pain was found to be 32%,52%,96%,72.8 %,72.9%, 56.6%,56.25%, 69 % in school teachers, bankers, dentists, nurses, clinical physical therapist, health science students, Salesmen and computer users respectively in Pakistan. Low back pain is pain or discomfort in the lumbosacral region from the lower costal margin to the inferior gluteal fold.
This randomized control trial will be conducted in MDL2 of Foundation University College of Physical Therapy using non-probability purposive sampling. Participants will be briefed regarding the study objectives, procedure, risks and benefits of treament, voluntary participation and right to withdraw. Written informed consent will be taken from all the participants before conducting the research. Details of exercise program will be explained to them. Diagnostic tests will be applied to confirm the Low back pain. Slump test will be used for this purpose. Then the selected participants will be randomized into 2 groups(experimental group and control group)via lottery method. Participants will complete Numeric Rating Pain Scale(NRPS) for pain. Lumbar ROM and spatiotemporal gait parameters will be noted. All of these measurements will be taken at baseline, after 1 week and then after 2 weeks of intervention.
The treatment protocol of both groups is as follows:
Group 1(Experimental group): Conservative management including hot pack, TENS and muscle stretching along with ELDOA (each position will be maintained as per the tolerance of the patient).
Group 2(Control group): Conservative management including hot pack, TENS and muscle stretching along with slump stretching (position will be maintained as per the tolerance of the patient).
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Conventional Physical Therapy, Slump Stretching, ELDOA
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical TherapyProcedure or surgery
Moist heat therapy for 10 minutes for 3 times per week (alternatively) for 2 weeks.
TENS was applied for 15 minutes, 3 times per week (alternatively) for 2 weeks. Stretching protocol for deep lumbar spinal muscles was employed. The frequency was 3 times per week (alternatively) for 2 weeks.
Slump StretchingProcedure or surgery
Slump stretching will be performed with the patient in the long sitting position with the patient's feet against the wall to assure the ankle remained in 0 degree dorsiflexion. The therapist will apply over pressure to the cervical spine flexion to the point where the patient's symptoms will be reproduced. The position will be held for 30 s. A total of 5 repetitions will be completed.
ELDOAProcedure or surgery
ELDOA will be performed as per the tolerance of the patient (Max hold time=60sec) for 2 weeks (alternatively). For L4/L5 spinal segment patient sits on the floor, arms at the side legs relaxed.
For L5/S1 segment the patient lies on his or her side with torso perpendicular to a wall with the sitz bone pressing into the wall. The patient swing the legs up so that he or she is lying on his or her back with the legs perpendicular up the wall and the sitz bone pressing into the wall. The arms are lying by the sides.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Treatment protocol given to both groups will be carried out for 3 sessions per week for 2 weeks.
It will comprise of hot pack for 10 minutes in prone position. Stretching protocol for shortened muscles. Frequency would be: 3 times per week (alternatively) for 1st week and 2nd week.
ELDOA. As per the tolerance of the patient. (Max hold time=60sec) For 2 weeks (alternatively). Receives: Procedure: Conventional Physical Therapy; Procedure: ELDOA |
| Group B | Active comparator | Treatment protocol given to both groups will be carried out for 3 sessions per week for 2 weeks.
It will comprise of hot pack for 10 minutes. Stretching protocol for shortened muscles. Frequency would be: 3 times per week (alternatively) for 1st week and 2nd week.
Slump Stretching: Slump stretching will be performed with the patient in the long sitting position with the patient's feet against the wall to assure the ankle remained in 0 degree dorsiflexion. The therapist will apply over pressure to the cervical spine flexion to the point where the patient's symptoms will be reproduced. The position will be held for 30 s. A total of 5 repetitions will be completed Receives: Procedure: Conventional Physical Therapy; Procedure: Slump Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar ROM
Inclinometer will be used to measure the lumbar ROM. One inclinometer is placed on T12 spinous process and the second inclinometer is placed on S1 spinous process of participant. The patient is asked to perform forward flexion, extension and lateral flexion, The range of motion is recorded by subtracting the value on lower inclinometer from upper inclinometer
Measured: 2 weeks
Gait speed:
Gait speed = distance(m) x time(s)
Measured: 2 weeks
Cycle time
Cycle time(s) = time(s) x2/steps counted
Measured: 2 weeks
Cadence
Cadence(steps/min) = steps counted x 60/time(s)
Measured: 2 weeks
Stride Length
SL (m)=Speed(m/s)x cycle time(s)
Measured: 2 weeks
Pain intensity
The numeric pain rating scale is a pain assessment tool that is self-reported or given by a clinician and consists of a numerical point scale with extreme values ranging from "no pain" to "severe pain." O means no pain whereas 10 means severe pain.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start7 Mar 2023
- Primary completion5 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Model description
- This study is a randomized controlled trial which will consist of two groups. Once will receive conventional physical therapy and the second will receive conventional physical therapy and slump stretching. Both groups will be recruited concurrently.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108661
- Sponsor's protocol ID
- FUI/CTR/2023/21
- 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ELDOA and Slump Stretching on Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06108661
- Acronym / sponsor ID
- FUI/CTR/2023/21
- Conditions
- Low Back Pain, Mechanical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 5 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 31 Oct 2023 (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 title of this study is Shirt term effects of ELDOA and slump steyching in mechanical low back pain. Previous studies have identified the effects of ELDOA and slump stretching on mechanical low back pain, but their short term effects have not been compared. This study will focus on the comparison of these techniques and their effectiveness in patients with mechanical low back pain. The purpose of this study is to compare the short term effects of ELDOA and slump stretching on spatiotemporal gait parameters, lumbar ROM and pain in patients with mechanical low back pain.
Spatiotemporal gait parameters will be measured by using formulas. Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will be allocated to either of the groups through a sealed opaque envelope method. ELODA and slump stretching will be given to groups A and B respectively, along with conventional physical therapy treatment. Inclinometer, NPRS and formulas for spatiotemporal gait parameters will be used as outcome measures.
Detailed description
Low back pain is one of the most prevalent musculoskeletal conditions worldwide. Amongst the general population, more than 70% of the people experience low back pain at some time in their lifetime. The prevalence of low back pain was found to be 32%,52%,96%,72.8 %,72.9%, 56.6%,56.25%, 69 % in school teachers, bankers, dentists, nurses, clinical physical therapist, health science students, Salesmen and computer users respectively in Pakistan. Low back pain is pain or discomfort in the lumbosacral region from the lower costal margin to the inferior gluteal fold.
This randomized control trial will be conducted in MDL2 of Foundation University College of Physical Therapy using non-probability purposive sampling. Participants will be briefed regarding the study objectives, procedure, risks and benefits of treament, voluntary participation and right to withdraw. Written informed consent will be taken from all the participants before conducting the research. Details of exercise program will be explained to them. Diagnostic tests will be applied to confirm the Low back pain. Slump test will be used for this purpose. Then the selected participants will be randomized into 2 groups(experimental group and control group)via lottery method. Participants will complete Numeric Rating Pain Scale(NRPS) for pain. Lumbar ROM and spatiotemporal gait parameters will be noted. All of these measurements will be taken at baseline, after 1 week and then after 2 weeks of intervention.
The treatment protocol of both groups is as follows:
Group 1(Experimental group): Conservative management including hot pack, TENS and muscle stretching along with ELDOA (each position will be maintained as per the tolerance of the patient).
Group 2(Control group): Conservative management including hot pack, TENS and muscle stretching along with slump stretching (position will be maintained as per the tolerance of the patient).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial which will consist of two groups. Once will receive conventional physical therapy and the second will receive conventional physical therapy and slump stretching. Both groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Conventional Physical Therapy, Procedure: ELDOATreatment protocol given to both groups will be carried out for 3 sessions per week for 2 weeks. It will comprise of hot pack for 10 minutes in prone position. Stretching protocol for shortened muscles. Frequency would be: 3 times per week (alternatively) for 1st week and 2nd week. ELDOA. As per the tolerance of the patient. (Max hold time=60sec) For 2 weeks (alternatively). |
| Group B | Active comparator | Procedure: Conventional Physical Therapy, Procedure: Slump StretchingTreatment protocol given to both groups will be carried out for 3 sessions per week for 2 weeks. It will comprise of hot pack for 10 minutes. Stretching protocol for shortened muscles. Frequency would be: 3 times per week (alternatively) for 1st week and 2nd week. Slump Stretching: Slump stretching will be performed with the patient in the long sitting position with the patient's feet against the wall to assure the ankle remained in 0 degree dorsiflexion. The therapist will apply over pressure to the cervical spine flexion to the point where the patient's symptoms will be reproduced. The position will be held for 30 s. A total of 5 repetitions will be completed |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age group: 18-45 years old
- Both males and females
- Patients with pain intensity of at least 5 on NPRS
- Positive slump test
Key exclusion criteria (11 listed)
- Any congenital deformities
- Demonstrated neurological deficit
- Pregnant females
- History of spinal surgery
- Spondylolisthesis
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 |
|---|---|---|
| Conventional Physical TherapyMoist heat therapy for 10 minutes for 3 times per week (alternatively) for 2 weeks. TENS was applied for 15 minutes, 3 times per week (alternatively) for 2 weeks. Stretching protocol for deep lumbar spinal muscles was employed. The frequency was 3 times per week (alternatively) for 2 weeks. | Procedure or surgery | Group A, Group B |
| Slump StretchingSlump stretching will be performed with the patient in the long sitting position with the patient's feet against the wall to assure the ankle remained in 0 degree dorsiflexion. The therapist will apply over pressure to the cervical spine flexion to the point where the patient's symptoms will be reproduced. The position will be held for 30 s. A total of 5 repetitions will be completed. | Procedure or surgery | Group B |
| ELDOAELDOA will be performed as per the tolerance of the patient (Max hold time=60sec) for 2 weeks (alternatively). For L4/L5 spinal segment patient sits on the floor, arms at the side legs relaxed. For L5/S1 segment the patient lies on his or her side with torso perpendicular to a wall with the sitz bone pressing into the wall. The patient swing the legs up so that he or she is lying on his or her back with the legs perpendicular up the wall and the sitz bone pressing into the wall. The arms are lying by the sides. | Procedure or surgery | Group A |
Primary outcome
Lumbar ROM
Time frame: 2 weeks
Inclinometer will be used to measure the lumbar ROM. One inclinometer is placed on T12 spinous process and the second inclinometer is placed on S1 spinous process of participant. The patient is asked to perform forward flexion, extension and lateral flexion, The range of motion is recorded by subtracting the value on lower inclinometer from upper inclinometer
Gait speed:
Time frame: 2 weeks
Gait speed = distance(m) x time(s)
Cycle time
Time frame: 2 weeks
Cycle time(s) = time(s) x2/steps counted
Cadence
Time frame: 2 weeks
Cadence(steps/min) = steps counted x 60/time(s)
Stride Length
Time frame: 2 weeks
SL (m)=Speed(m/s)x cycle time(s)
Pain intensity
Time frame: 2 weeks
The numeric pain rating scale is a pain assessment tool that is self-reported or given by a clinician and consists of a numerical point scale with extreme values ranging from "no pain" to "severe pain." O means no pain whereas 10 means severe pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy, Slump Stretching and ELDOA in people with Low Back Pain, Mechanical, run by Foundation University Islamabad 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 11 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 Maheen Farooq, MS-MSKPT* (03354222508, mahe.farooq1896@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar ROM (time frame: 2 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?
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.