Low Back PainNCT03631082
Effects of Slump Stretching vs Lumbar Mobilization With Exercises in Relieving Non-radiculating Low Back Pain
A study testing Slump stretching and Lumbar mobilization in people with Low Back Pain, run by Isra University.
Trial summary
This study will be conducted to determine the effects of slump stretching vs lumbar mobilization with exercises in relieving non-radiculating low back pain. There will be two groups; Group I will receive Slump stretching along with standardized exercises and Group II will receive Lumbar mobilizations along with… Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Slump stretching and Lumbar mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Jan 2019
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals with Non-Radiculating Low back pain
- Test:
- Slump test=positive ii. Straight leg raise=negative
Who cannot join
- Individuals with Radiculating Low Back pain,History of spinal surgery, Disc herniation,Pregnant women, Major diseases (e.g. stroke)
About this study
This study will be conducted to determine the effects of slump stretching vs lumbar mobilization with exercises in relieving non-radiculating low back pain. There will be two groups; Group I will receive Slump stretching along with standardized exercises and Group II will receive Lumbar mobilizations along with standardized exercises.
Read the detailed description
Physical therapist commonly examines and treats patients with low back pain. For this purpose, they utilize a wide range of interventions for the management of Low back pain.
The rhythmical movement is thought to modulate pain and muscle spasm by stimulating receptors within the mobilized structures while, In recent years, neurodynamic test procedures, have also been used as interventions to potentially resolve abnormal physiology within the nervous system.
So for this purpose not only the present study can provide an additional evidence to the literature but also can can also demonstrates a structured Physiotherapy plan for treating the Non-Radiculating Low back pain
- Conditions
- Low Back Pain
- Being tested
- Slump stretching, Lumbar mobilization
- Keywords
- effects, slump stretching, lumbar mobilization, non radiculating, Low back pain, exercises, quality of life, modified oswestry low back pain disability, numeric pain rating scale, fear avoidance beliefs
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slump stretchingOther
Slump stretching will be provided to this group along with standardized exercises.
Lumbar mobilizationOther
Lumbar mobilizations will be provided to this group along with standardized exercises.
| Study group | Role | What they receive |
|---|---|---|
| Slump stretching group | Experimental | Slump stretching will be performed with the patient in the long sitting position. The position will be held for 30 seconds. A total of 5 repetitions will be completed.
Patients will also complete a standardized exercise program consisting of pelvic tilts, bridging, wall squats, and quadruped alternate arms/legs activities as described by Cleland et al.
Patients will perform 10 repetitions of each exercise. Receives: Other: Slump stretching |
| Lumbar mobilization group | Active comparator | Maitland Grade 1 - 2 Posterior to anterior lumbar spine mobilization will be applied for 30 - 45 seconds for all segments through L1 to L5 at rate of 1 oscillation per 2 seconds.
Patients will also complete a standardized exercise program consisting of pelvic tilts, bridging, wall squats, quadruped alternate arms/legs activities as described by Cleland et al.
Patients will perform 10 repetitions of each exercise. Receives: Other: Lumbar mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.
Measured: 2 weeks
Modified Oswestry Low Back Pain Disability Questionnaire
The questionnaire has been designed to give the therapist information as to how the back pain has affected the ability to manage in everyday life.
Measured: 2 weeks
Short-Form Health Survey (SF-36)
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.
Measured: 2 weeks
Secondary outcomes (2)
Fear-Avoidance Beliefs Questionnaire
It consist of two scales; Scale 1: fear-avoidance beliefs about work Scale 2: fear-avoidance beliefs about physical activity
Measured: 2 weeks
Active range of motion of lumbar spine.
It includes; lumbar flexion lumbar extension left lateral flexion right lateral flexion
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 posted15 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- The two groups will be Slump stretching group and Lumbar mobilization group. All physical therapy techniques in both groups will be applied 3 times in a week up to 2 weeks with each session consisting of 25-40 minutes. Group 1 will receive slump stretching along with standardized exercises while group 2 will recieve lumbar mobilization along with standardized exercises. Demographic details of the patients will be collected at baseline (1st Visit) while Modified Oswestry Low Back Pain Disability Questionnaire,Numeric pain rating scale,Fear-Avoidance Beliefs Questionnaire,Active range of motion (AROM) of lumbar spine and Short-Form Health Survey (SF-36) will be measured at baseline, 1st week, and final week.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sundus Iftikhar, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631082
- Sponsor's protocol ID
- IIRS-IUISB/SMMPT/001
- Status last verified
- Aug 2018
- First submitted
- 12 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Slump Stretching vs Lumbar Mobilization With Exercises in Relieving Non-radiculating Low Back Pain
- ClinicalTrials.gov ID
- NCT03631082
- Acronym / sponsor ID
- IIRS-IUISB/SMMPT/001
- Conditions
- Low Back Pain
- Keywords
- effects, slump stretching, lumbar mobilization, non radiculating, Low back pain, exercises, quality of life, modified oswestry low back pain disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 15 Aug 2018 (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.
This study will be conducted to determine the effects of slump stretching vs lumbar mobilization with exercises in relieving non-radiculating low back pain. There will be two groups; Group I will receive Slump stretching along with standardized exercises and Group II will receive Lumbar mobilizations along with standardized exercises.
Detailed description
Physical therapist commonly examines and treats patients with low back pain. For this purpose, they utilize a wide range of interventions for the management of Low back pain.
The rhythmical movement is thought to modulate pain and muscle spasm by stimulating receptors within the mobilized structures while, In recent years, neurodynamic test procedures, have also been used as interventions to potentially resolve abnormal physiology within the nervous system.
So for this purpose not only the present study can provide an additional evidence to the literature but also can can also demonstrates a structured Physiotherapy plan for treating the Non-Radiculating Low back pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The two groups will be Slump stretching group and Lumbar mobilization group. All physical therapy techniques in both groups will be applied 3 times in a week up to 2 weeks with each session consisting of 25-40 minutes. Group 1 will receive slump stretching along with standardized exercises while group 2 will recieve lumbar mobilization along with standardized exercises. Demographic details of the patients will be collected at baseline (1st Visit) while Modified Oswestry Low Back Pain Disability Questionnaire,Numeric pain rating scale,Fear-Avoidance Beliefs Questionnaire,Active range of motion (AROM) of lumbar spine and Short-Form Health Survey (SF-36) will be measured at baseline, 1st week, and final week.
| Arm | Type | Receives |
|---|---|---|
| Slump stretching group | Experimental | Other: Slump stretchingSlump stretching will be performed with the patient in the long sitting position. The position will be held for 30 seconds. A total of 5 repetitions will be completed. Patients will also complete a standardized exercise program consisting of pelvic tilts, bridging, wall squats, and quadruped alternate arms/legs activities as described by Cleland et al. Patients will perform 10 repetitions of each exercise. |
| Lumbar mobilization group | Active comparator | Other: Lumbar mobilizationMaitland Grade 1 - 2 Posterior to anterior lumbar spine mobilization will be applied for 30 - 45 seconds for all segments through L1 to L5 at rate of 1 oscillation per 2 seconds. Patients will also complete a standardized exercise program consisting of pelvic tilts, bridging, wall squats, quadruped alternate arms/legs activities as described by Cleland et al. Patients will perform 10 repetitions of each exercise. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Individuals with Non-Radiculating Low back pain
- Slump test=positive ii. Straight leg raise=negative
Key exclusion criteria (1 listed)
- Individuals with Radiculating Low Back pain,History of spinal surgery, Disc herniation,Pregnant women, Major diseases (e.g. stroke)
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 |
|---|---|---|
| Slump stretchingSlump stretching will be provided to this group along with standardized exercises. | Other | Slump stretching group |
| Lumbar mobilizationLumbar mobilizations will be provided to this group along with standardized exercises. | Other | Lumbar mobilization group |
Primary outcome
Numeric pain rating scale
Time frame: 2 weeks
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.
Modified Oswestry Low Back Pain Disability Questionnaire
Time frame: 2 weeks
The questionnaire has been designed to give the therapist information as to how the back pain has affected the ability to manage in everyday life.
Short-Form Health Survey (SF-36)
Time frame: 2 weeks
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.
2 secondary outcomes
Fear-Avoidance Beliefs Questionnaire
Time frame: 2 weeks
Active range of motion of lumbar spine.
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Slump stretching and Lumbar mobilization in people with Low Back Pain, run by Isra University.
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 1 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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: 2 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?
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 Aug 2018.