Low Back PainNCT05708781
Efficacy of Core Strengthening and Intensive Dynamic Back Exercises in Patient With Low Back Pain
A study testing Core strengthening exercise and intensive dynamic back exercise in people with Low Back Pain, run by Najran University at 2 sites in 2 countries.
Trial summary
The study aimed to investigate the efficacy of core strengthening and intensive dynamic back exercises on pain, muscle strength, endurance, and functional disability in patients with chronic non-specific low back pain. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Core strengthening exercise and intensive dynamic back exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Dec 2022to 28 Sep 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 20-50 years
- chronic low back pain (>3 months),
Who cannot join
- Participants with low back pain related to cancer,
- infection,
- inflammatory arthropathy,
- high-velocity trauma,
- fracture
- low back pain associated with severe or progressive neurological deficits trauma
- pregnancy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Efficacy of Core Strengthening and Intensive Dynamic Back Exercises on Pain, Muscle Strength, Endurance, and Functional Disability in Patients With Chronic Non-specific Low Back Pain. a Randomized Comparative Study
The study aimed to investigate the efficacy of core strengthening and intensive dynamic back exercises on pain, muscle strength, endurance, and functional disability in patients with chronic non-specific low back pain.
Read the detailed description
The study will be based on a three-arm parallel group randomized control design. Forty-five participants with chronic non-specific low back pain will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into three groups A, B, and C. Experimental group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and core strengthening exercises while group B will receive the hot pack, active Stretching, isometric exercise intervention, and intensive dynamic back exercises, control group C will receive the hot pack, active Stretching, isometric exercise intervention.
- Conditions
- Low Back Pain
- Being tested
- Core strengthening exercise, intensive dynamic back exercise, Control group
- 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.
Core strengthening exerciseOther
- Isolated lumbar stabilization muscle training:
- Bridge track:
- Dead bug track:
- Quadruped Track:
- Supine Track:
- Side-support Track:
- Prone Track:
- Standing Track:
intensive dynamic back exerciseOther
- Trunk lifting Prone on a couch, hips at the edge, upper part of the body free but supported by the hands against the floor. Strap fixation over the calves. With hands on the forehead, the trunk is lifted to the greatest possible extension in hips and spine. If necessary, starting with support from physical therapist. During pauses a chair in front of the couch supports the patient.
- Leg lifting Standing by the end of the couch, leaning over to a prone position with the hips against the edge in 90 degree flexion, knees 45 degree and feet on the floor. Strap fixation over the chest. Straps around knees to keep legs together. Both legs are straightened and lifted to the greatest possible extension in hips and spine. Again support from physical therapist is necessary.
- Pull to neck Sitting on a tool with the arms straight and abducted over the head and hands grasping a weight lever. Against sub-maximal resistance the lever is pulled behind neck and shoulders.
Control groupOther
Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10- second relaxation) were given, and isometric exercise of the back((10 repetitions of two sets with 10 seconds hold) alternate days for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| CSE Group | Experimental | in addition to Conventional treatment, core strengthening exercise were given Receives: Other: Core strengthening exercise; Other: Control group |
| IDBE Group | Experimental | in addition to Conventional treatment, intensive dynamic back exercise were given Receives: Other: intensive dynamic back exercise; Other: Control group |
| Control Group | Active comparator | Conventional Treatment Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain
Measured: 6 Weeks
functional Limitation
Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.
Measured: 6 Weeks
Muscle Endurance
Muscle endurance was assessed by using timed endurance tests including the extensor endurance test, flexor endurance test and the side bridge test. The hold time was recorded in seconds once the patient was not able to maintain the respective endurance test position.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start20 Dec 2022
- Primary completion17 Aug 2023
- Study completion28 Sep 2023
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Najran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Ahmed, Najran University
- Investigators
- Hashim Ahmed, PhD, Principal investigator, Najran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708781
- Sponsor's protocol ID
- IE/IIMS&R/2022/43
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Core Strengthening and Intensive Dynamic Back Exercises on Pain, Muscle Strength, Endurance, and Functional Disability in Patients With Chronic Non-specific Low Back Pain. a Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05708781
- Acronym / sponsor ID
- IE/IIMS&R/2022/43
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Najran UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 1 Feb 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 study aimed to investigate the efficacy of core strengthening and intensive dynamic back exercises on pain, muscle strength, endurance, and functional disability in patients with chronic non-specific low back pain.
Detailed description
The study will be based on a three-arm parallel group randomized control design. Forty-five participants with chronic non-specific low back pain will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into three groups A, B, and C. Experimental group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and core strengthening exercises while group B will receive the hot pack, active Stretching, isometric exercise intervention, and intensive dynamic back exercises, control group C will receive the hot pack, active Stretching, isometric exercise intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CSE Group | Experimental | Other: Core strengthening exercise, Other: Control groupin addition to Conventional treatment, core strengthening exercise were given |
| IDBE Group | Experimental | Other: intensive dynamic back exercise, Other: Control groupin addition to Conventional treatment, intensive dynamic back exercise were given |
| Control Group | Active comparator | Other: Control groupConventional Treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 20-50 years
- chronic low back pain (>3 months),
Key exclusion criteria (7 listed)
- Participants with low back pain related to cancer,
- infection,
- inflammatory arthropathy,
- high-velocity trauma,
- fracture
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 |
|---|---|---|
| Core strengthening exercise1. Isolated lumbar stabilization muscle training: 2. Bridge track: 3. Dead bug track: 4. Quadruped Track: 5. Supine Track: 6. Side-support Track: 7. Prone Track: 8. Standing Track: | Other | CSE Group |
| intensive dynamic back exercise1. Trunk lifting Prone on a couch, hips at the edge, upper part of the body free but supported by the hands against the floor. Strap fixation over the calves. With hands on the forehead, the trunk is lifted to the greatest possible extension in hips and spine. If necessary, starting with support from physical therapist. During pauses a chair in front of the couch supports the patient. 2. Leg lifting Standing by the end of the couch, leaning over to a prone position with the hips against the edge in 90 degree flexion, knees 45 degree and feet on the floor. Strap fixation over the chest. Straps around knees to keep legs together. Both legs are straightened and lifted to the greatest possible extension in hips and spine. Again support from physical therapist is necessary. 3. Pull to neck Sitting on a tool with the arms straight and abducted over the head and hands grasping a weight lever. Against sub-maximal resistance the lever is pulled behind neck and shoulders. | Other | IDBE Group |
| Control groupHot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10- second relaxation) were given, and isometric exercise of the back((10 repetitions of two sets with 10 seconds hold) alternate days for six weeks. | Other | CSE Group, Control Group, IDBE Group |
Primary outcome
Pain Intensity
Time frame: 6 Weeks
The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain
functional Limitation
Time frame: 6 Weeks
Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.
Muscle Endurance
Time frame: 6 Weeks
Muscle endurance was assessed by using timed endurance tests including the extensor endurance test, flexor endurance test and the side bridge test. The hold time was recorded in seconds once the patient was not able to maintain the respective endurance test position.
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 22 Nov 2023.
- Individual participant dataSharing planned: No
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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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.
Hashim Ahmed, PhD principal investigator
Najran University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core strengthening exercise and intensive dynamic back exercise in people with Low Back Pain, run by Najran University at 2 sites in 2 countries.
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 2 inclusion and 7 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, Saudi Arabia. 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?
Pain Intensity (time frame: 6 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 22 Nov 2023.