Non-specific Low Back PainNCT05101200

Dose Response of Neural Mobilization on Hamstring Flexibility in Low Back Pain

A study testing High Dose Neural Mobilization Technique and Low Dose Neural Mobilization Technique in people with Non-specific Low Back Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Non-specific Low Back Pain
What is being tested?: High Dose Neural Mobilization Technique and Low Dose Neural Mobilization Technique
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 sitePakistan
Study dates: 1 Nov 2021to 30 May 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 18 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Low back pain > 3 months
No exercises for last 6 months
Non-specific LBP in its sub-acute \& chronic phase

Who cannot join

Specific causes of LBP (disc herniation, lumbar stenosis, spinal deformity, fracture, spondylolisthesis),
Central or peripheral neurologic signs
Systemic illness (tumor and rheumatologic diseases),
Psychiatric and mental deficits.
Patients who had undergone operations within 6 months

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

National orthopedic and specialist hospital
Rawalpindi, Punjab Province, 44000

Other trials in Pakistan

About this study

Official title: Dose Response of Neural Mobilization on Hamstring Flexibility in Patients With Non-specific Low Back Pain

This study will be a randomized control trial and will be conducted in Riphah International Hospital, National orthopedic and specialist hospital, Riphah international hospital and Chambeli institute of physiotherapy. A sample of 34 participants will be taken. Participants will be randomized into Group A and Group B through lottery method. Group A will receive High Dose Neural Mobilization Technique, Hot pack for 15 minutes, strengthening exercises with 10rep/8sets , strengthening exercises for quadriceps and static stretching exercise for hamstring with 10 rep/8sets, While Group B will receive Low Dose Neural Mobilization Technique with minimal intensity, hot pack: 15 minutes, strengthening exercises with 10rep/4sets. Both groups will be given session of 40 min/day, 2 days/week for 4 weeks, assessment will be done at baseline, at the end of 1st week, 2nd week, 3rd week \& at the end of 4th week. The outcome measure will be Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), Active Knee Extension test (AKE) and Lumbar flexion by Schober method. Data will be analyzed be SPSS 22.

Conditions: Non-specific Low Back Pain
Being tested: High Dose Neural Mobilization Technique, Low Dose Neural Mobilization Technique
Keywords: Neural Mobilization Technique, Oswestry Disability Index, Active Knee Extension Test, Numeric Pain Rating Scale, Lumbar flexion by Schober method

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Dose Neural Mobilization TechniqueOther
Patients in This Group will receive the high dose neural mobilization along with hot pack, strengthening exercises, Neural mobilization technique (slump, sciatic). Participants in the NMG will be asked to actively perform knee extension, ankle dorsiflexion, and head extension in a slumped posture (body and neck semi flexion) followed by simultaneous ankle plantar flexion together with knee and head flexion, Hot pack for 15 minutes, Strengthening exercises of muscles with 10 /8sets. Strengthening exercises of quadriceps with10 rep/8sets, Static stretching exercise for hamstring muscle with 10 rep/8sets, Group A will be given session of 40 min/day, 2 days/week for 4 weeks.
Low Dose Neural Mobilization TechniqueOther
Patients in this Group will receive the same treatment as group A but with less intensity and low dosage. Hot pack: 15 minutes, Strengthening exercises of muscles with 10 rep/4sets, Static stretching exercise for hamstring muscle with 10 rep/4sets. Group B will be given session of 40min/day, 2 days/week for 4weeks.

Study groups in NCT05101200
Study group	Role	What they receive
High Dose Neural Mobilization Technique	Experimental	Patients in this Group will receive High Dose Neural Mobilization Technique Receives: Other: High Dose Neural Mobilization Technique
Low Dose Neural Mobilization Technique	Experimental	Patients in this Group will receive Low Dose Neural Mobilization Technique Receives: Other: Low Dose Neural Mobilization Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale that is a uni-dimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or "worst pain imaginable"). The intrarater reliability with ICC = 0.67.
Measured: 4 Weeks
Oswestry Disability Index (ODI)
Oswestry Low Back Pain Disability Index(ODI) is a questionnaire reported by the patient itself for low back pain. The questionnaire into ten sections is divided and used to assess daily living activities limitations. Scored on scales of 0- 5 for each section, greatest disability is represented by 5. To calculate index summed scores is divided by the total score, then by 100 multiplied and as percentage it is expressed. With degree of disability associated are the scores indicating minimal to bed bound disability. 0% to 20% scores shows minimal disability, moderate disability indicated by scores from 20% to 40%, severe disability indicated by from 40% to 60% scores, 60% to 80% indicates crippled; and bedbound or exaggerating indicated by scores from 80% to 100%. Test-retest has high reliability (r = 0.83 to 0.99).
Measured: 4 Weeks
Active Knee Extension test for hamstring flexibility
AKE test as known as active knee extension test is used to assess the flexibility and available Range of motion of hamstring muscle.The range of active knee extension in the position of hip flexion is easily assessed. M. Shamsi, Meriam et.al discussed the reliability and validity of this test and proved it as a valid tool for measurement of shortness in hamstring muscle.
Measured: 4 Weeks
Lumbar flexion by Schober method
For the measurement of OST, the participant stood erect while the lumbosacral junction was marked as indicated by the dimples of Venus. A second mark was placed 10 cm above the junction. The participant was then asked to bend forward as far as possible, and the stretched distance was indicated as the OST in cm.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202130 May 2022

First posted1 Nov 2021
Study start1 Nov 2021
Primary completion30 May 2022
Study completion30 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-specific Low Back PainStudies 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: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05101200
Sponsor's protocol ID: Rabia Liaquat
Status last verified: Dec 2022
First submitted: 19 Oct 2021
Last updated: 15 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
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Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
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McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
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Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
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Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)

All Non-specific Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Response of Neural Mobilization on Hamstring Flexibility in Patients With Non-specific Low Back Pain
ClinicalTrials.gov ID: NCT05101200
Acronym / sponsor ID: Rabia Liaquat
Conditions: Non-specific Low Back Pain
Keywords: Neural Mobilization Technique, Oswestry Disability Index, Active Knee Extension Test, Numeric Pain Rating Scale, Lumbar flexion by Schober method
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 1 Nov 2021 (actual)
Primary completion: 30 May 2022 (actual)
Study completion: 30 May 2022 (actual)
First posted: 1 Nov 2021 (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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High Dose Neural Mobilization Technique	Experimental	Other: High Dose Neural Mobilization TechniquePatients in this Group will receive High Dose Neural Mobilization Technique
Low Dose Neural Mobilization Technique	Experimental	Other: Low Dose Neural Mobilization TechniquePatients in this Group will receive Low Dose Neural Mobilization Technique

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Low back pain > 3 months
No exercises for last 6 months
Non-specific LBP in its sub-acute \& chronic phase

Key exclusion criteria (5 listed)

Specific causes of LBP (disc herniation, lumbar stenosis, spinal deformity, fracture, spondylolisthesis),
Central or peripheral neurologic signs
Systemic illness (tumor and rheumatologic diseases),
Psychiatric and mental deficits.
Patients who had undergone operations within 6 months

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
High Dose Neural Mobilization TechniquePatients in This Group will receive the high dose neural mobilization along with hot pack, strengthening exercises, Neural mobilization technique (slump, sciatic). Participants in the NMG will be asked to actively perform knee extension, ankle dorsiflexion, and head extension in a slumped posture (body and neck semi flexion) followed by simultaneous ankle plantar flexion together with knee and head flexion, Hot pack for 15 minutes, Strengthening exercises of muscles with 10 /8sets. Strengthening exercises of quadriceps with10 rep/8sets, Static stretching exercise for hamstring muscle with 10 rep/8sets, Group A will be given session of 40 min/day, 2 days/week for 4 weeks.	Other	High Dose Neural Mobilization Technique
Low Dose Neural Mobilization TechniquePatients in this Group will receive the same treatment as group A but with less intensity and low dosage. Hot pack: 15 minutes, Strengthening exercises of muscles with 10 rep/4sets, Static stretching exercise for hamstring muscle with 10 rep/4sets. Group B will be given session of 40min/day, 2 days/week for 4weeks.	Other	Low Dose Neural Mobilization Technique

Primary outcome

Numeric Pain Rating Scale (NPRS)
Time frame: 4 Weeks
The Numeric Pain Rating Scale that is a uni-dimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or "worst pain imaginable"). The intrarater reliability with ICC = 0.67.
Oswestry Disability Index (ODI)
Time frame: 4 Weeks
Oswestry Low Back Pain Disability Index(ODI) is a questionnaire reported by the patient itself for low back pain. The questionnaire into ten sections is divided and used to assess daily living activities limitations. Scored on scales of 0- 5 for each section, greatest disability is represented by 5. To calculate index summed scores is divided by the total score, then by 100 multiplied and as percentage it is expressed. With degree of disability associated are the scores indicating minimal to bed bound disability. 0% to 20% scores shows minimal disability, moderate disability indicated by scores from 20% to 40%, severe disability indicated by from 40% to 60% scores, 60% to 80% indicates crippled; and bedbound or exaggerating indicated by scores from 80% to 100%. Test-retest has high reliability (r = 0.83 to 0.99).
Active Knee Extension test for hamstring flexibility
Time frame: 4 Weeks
AKE test as known as active knee extension test is used to assess the flexibility and available Range of motion of hamstring muscle.The range of active knee extension in the position of hip flexion is easily assessed. M. Shamsi, Meriam et.al discussed the reliability and validity of this test and proved it as a valid tool for measurement of shortness in hamstring muscle.
Lumbar flexion by Schober method
Time frame: 4 weeks
For the measurement of OST, the participant stood erect while the lumbosacral junction was marked as indicated by the dimples of Venus. A second mark was placed 10 cm above the junction. The participant was then asked to bend forward as far as possible, and the stretched distance was indicated as the OST in cm.

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 15 Dec 2022.
Individual participant dataSharing planned: No

Related trials for Non-specific Low Back Pain

Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)

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.

Waqar Ahmed Awan, Ms-OMPT 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?

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 5 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 15 Dec 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?

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 (NPRS) (time frame: 4 Weeks). The study lists 4 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 NCT05101200.

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 Dec 2022.