Mechanical Low Back PainNCT06407206
Effects of Sub Occipital Muscle Inhibition Technique in Mechanical Low Back Pain
A study testing Sub occipital muscle inhibition technique and conventional therapy and conventional therapy in people with Mechanical Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of study is to determine the effects of sub occipital muscle inhibition technique in mechanical low back pain, hamstring muscle flexibility, lumbar ranges and functional disability. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Sub occipital muscle inhibition technique and conventional therapy and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 1 Jul 2024
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic mechanical low back pain > 12 weeks
- Patients with hamstring tightness having popliteal angle more than 30 degrees.
- Negative sacroiliac distraction test to exclude sacroiliac joint pain
Who cannot join
- Acute severe low back pain
- Patients with hamstring injury
- Active tumor or infection
- Fractures of cervical and lumbar spine
- History of previous lumbar, hip and knee surgery
- Migraine
Show all 10Show fewer
- Fever
- Sacroiliac joint dysfunction
- Cauda equine syndrome
- Patients having cognitive or mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of study is to determine the effects of sub occipital muscle inhibition technique in mechanical low back pain, hamstring muscle flexibility, lumbar ranges and functional disability. This study will focus on either this technique have effects on reliving lumbar pain, improving flexibility of hamstring muscles and lumbar ranges or not.
Read the detailed description
Low back pain (LBP) is a common health condition, 70% of population of all ages is suffering from low back pain. Females have higher prevalence of low back pain than males. Individuals with low back pain experience muscle stiffness tension and pain in the back of body between the lower edge of 12th rib and the lower border of gluteal creases in the lumbo-sacral area (from L1-S1 vertebra) with a duration of more than three months. Low back pain can be mechanical in nature and is not associated with any other pathology .The primary etiological factors of mechanical low back pain is repetitive trauma and overuse.
Hamstring is a multi - joint muscle complex which consists of three muscles ( semitendinosus, semimembranosus and biceps femoris muscle) that covers the posterior thigh extending from ischial tuberosity to the medial and lateral aspects of the knee joint, performing flexion of knee and extension of hip joint. Hamstring muscle is prone to tightness, its flexibility have a vital role in maintaining the normal lumbar spine mechanics. Hamstring tightness is common among ages of 18-25 years with about 62% to 82% prevalence .Hamstring shortening during spinal flexion limits anterior pelvic tilting resulting in higher compressive loads on lumbar spine. It will place extreme pressure on lumbar extensors, involved in maintaining pelvic motion which will result in LBP .
Sub occipital muscle inhibition technique is a technique that results in relaxing the tense fascia and sub occipital muscles .It can be relaxed by applying pressure to sub occipital region while patient is lying in supine position. It is able to relax the fascia and results in increasing hamstring flexibility, which further results in reducing low back pain, increasing lumbar spine mobility and reducing functional limitations
- Conditions
- Mechanical Low Back Pain
- Being tested
- Sub occipital muscle inhibition technique and conventional therapy, conventional therapy
- Keywords
- mechanical low back pain, sub occipital muscle inhibition, hamstring flexibility
- 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.
Sub occipital muscle inhibition technique and conventional therapyOther
Patient is in supine position Therapist sits near the head of the participant and places his hand below the head of the participant With the pads of hand therapist palpates the arch of atlas between the occipital protuberance and spinous process of axis and place the middle and ring finger over it by flexing the metacarpophalangeal joint in 90 degrees of flexion, base of skull will rest on hands Pressure is exerted in upward direction towards the therapist and is maintained for two minutes so that the muscle scan relax Participants are guided to keep their eyes close in order to avoid movement which affects the tone of sub occipital muscle
conventional therapyOther
Transcutaneous electrical nerve stimulation at lower back and hamstring muscles (pulse rate: 4Hertz, pulse duration: 150µs for 15mins) Hot pack ( 15mins),Ankle pumps (15 reps with 5 sec hold), Knee Range of motions (flexion and extension,10 reps),Quadriceps set (10 reps,5 sec hold),Vastus Medialis oblique (10 reps 5 sec hold),Gluteus sets (10 reps, 5 sec hold),Single knee to chest (10 reps with 10 sec hold) McKenzie exercises (10 reps with 10 sec hold and 10 sec rest),Stretching of calf and hamstring muscles (passive stretching,7 reps with 5 sec hold).
| Study group | Role | What they receive |
|---|---|---|
| Sub occipital muscle inhibition technique along with conventional therapy | Experimental | Patient is in supine position Therapist sits near the head of the participant and places his hand below the head of the participant With the pads of hand therapist palpates the arch of atlas between the occipital protuberance and spinous process of axis and place the middle and ring finger over it by flexing the metacarpophalangeal joint in 90 degrees of flexion, base of skull will rest on hands Pressure is exerted in upward direction towards the therapist and is maintained for two minutes so that the muscle scan relax Participants are guided to keep their eyes close in order to avoid movement which affects the tone of sub occipital muscle Receives: Other: Sub occipital muscle inhibition technique and conventional therapy |
| conventional therapy | Other | Transcutaneous electrical nerve stimulation at lower back and hamstring muscles (pulse rate: 4Hertz, pulse duration: 150µs for 15mins) Hot pack ( 15mins),Ankle pumps (15 reps with 5 sec hold), Knee Range of motions (flexion and extension,10 reps),Quadriceps set (10 reps,5 sec hold),Vastus Medialis oblique (10 reps 5 sec hold),Gluteus sets (10 reps, 5 sec hold),Single knee to chest (10 reps with 10 sec hold) McKenzie exercises (10 reps with 10 sec hold and 10 sec rest),Stretching of calf and hamstring muscles (passive stretching,7 reps with 5 sec hold). Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active knee extension test:
Active knee extension test is performed for assessing the flexibility of hamstring muscles. The test is performed by positioning the participant in supine position, hip is placed at 90 degrees of flexion while opposite leg is stabilized in order to avoid hip flexion. The lumbar spine is in neutral position. The fulcrum of goniometer is placed over the lateral condyle of femur, proximal arm of goniometer is placed on the lateral surface of femur keeping the greater trochanter for reference and the distal arm is placed along the lateral surface of fibula with lateral malleolus keeping for reference. The participant is then asked to actively extend the knee till the point of pain or maximum tolerable stretch to hamstring muscle, measurements are then recorded from goniometer. its reliability with intra-class correlation coefficient (ICC) of 0.87 for dominant knee and 0.81 for non-dominant knee. .
Measured: two weeks
Numeric Pain Rating Scale (NPRS):
The Numeric Pain Rating Scale (NPRS) is used to measure the subjective intensity of pain. The NPRS is an eleven-point scale ranging from 0 to 10. In which "0" is for no pain and "10" is for the most intense/worst pain, while the NPRS exhibited moderate reliability (ICC = 0.27-0.84)
Measured: two weeks
Inclinometer for range of motion
An inclinometer is a commonly used device in physiotherapy to measure angles and the range of motion (ROM) of joints.it consists of a sensor which is sensitive to gravity and measures the angles, angle is then displayed on a digital display or a dial. The angle of the inclinometer will change as the joint moves. The maximum angle reached is the ROM of the joint. Inter-rater reliability of inclinometer is ICCs 0.71-0.87.
Measured: two weeks
Oswestry disability index questionnaire (ODI):
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researcher use to measure a patient\'s permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Questionnaire examines the level of disability in 10 everyday activities of daily living which includes pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social interaction, travel, employment/ homemaking. Each item consists of 6 statements which are scored from 0-5, 0 indicating least disability and 5 indicates the greatest, total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability. Test-retest reliability was consistently high across studies (mean ICC value of 0.937 ± 0.032).
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Apr 2024
- Primary completion10 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407206
- Sponsor's protocol ID
- REC OMAIRAH AIEN
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sub Occipital Muscle Inhibition Technique in Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06407206
- Acronym / sponsor ID
- REC OMAIRAH AIEN
- Conditions
- Mechanical Low Back Pain
- Keywords
- mechanical low back pain, sub occipital muscle inhibition, hamstring flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 May 2024 (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 aim of study is to determine the effects of sub occipital muscle inhibition technique in mechanical low back pain, hamstring muscle flexibility, lumbar ranges and functional disability. This study will focus on either this technique have effects on reliving lumbar pain, improving flexibility of hamstring muscles and lumbar ranges or not.
Detailed description
Low back pain (LBP) is a common health condition, 70% of population of all ages is suffering from low back pain. Females have higher prevalence of low back pain than males. Individuals with low back pain experience muscle stiffness tension and pain in the back of body between the lower edge of 12th rib and the lower border of gluteal creases in the lumbo-sacral area (from L1-S1 vertebra) with a duration of more than three months. Low back pain can be mechanical in nature and is not associated with any other pathology .The primary etiological factors of mechanical low back pain is repetitive trauma and overuse.
Hamstring is a multi - joint muscle complex which consists of three muscles ( semitendinosus, semimembranosus and biceps femoris muscle) that covers the posterior thigh extending from ischial tuberosity to the medial and lateral aspects of the knee joint, performing flexion of knee and extension of hip joint. Hamstring muscle is prone to tightness, its flexibility have a vital role in maintaining the normal lumbar spine mechanics. Hamstring tightness is common among ages of 18-25 years with about 62% to 82% prevalence .Hamstring shortening during spinal flexion limits anterior pelvic tilting resulting in higher compressive loads on lumbar spine. It will place extreme pressure on lumbar extensors, involved in maintaining pelvic motion which will result in LBP .
Sub occipital muscle inhibition technique is a technique that results in relaxing the tense fascia and sub occipital muscles .It can be relaxed by applying pressure to sub occipital region while patient is lying in supine position. It is able to relax the fascia and results in increasing hamstring flexibility, which further results in reducing low back pain, increasing lumbar spine mobility and reducing functional limitations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub occipital muscle inhibition technique along with conventional therapy | Experimental | Other: Sub occipital muscle inhibition technique and conventional therapyPatient is in supine position Therapist sits near the head of the participant and places his hand below the head of the participant With the pads of hand therapist palpates the arch of atlas between the occipital protuberance and spinous process of axis and place the middle and ring finger over it by flexing the metacarpophalangeal joint in 90 degrees of flexion, base of skull will rest on hands Pressure is exerted in upward direction towards the therapist and is maintained for two minutes so that the muscle scan relax Participants are guided to keep their eyes close in order to avoid movement which affects the tone of sub occipital muscle |
| conventional therapy | Other | Other: conventional therapyTranscutaneous electrical nerve stimulation at lower back and hamstring muscles (pulse rate: 4Hertz, pulse duration: 150µs for 15mins) Hot pack ( 15mins),Ankle pumps (15 reps with 5 sec hold), Knee Range of motions (flexion and extension,10 reps),Quadriceps set (10 reps,5 sec hold),Vastus Medialis oblique (10 reps 5 sec hold),Gluteus sets (10 reps, 5 sec hold),Single knee to chest (10 reps with 10 sec hold) McKenzie exercises (10 reps with 10 sec hold and 10 sec rest),Stretching of calf and hamstring muscles (passive stretching,7 reps with 5 sec hold). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chronic mechanical low back pain > 12 weeks
- Patients with hamstring tightness having popliteal angle more than 30 degrees.
- Negative sacroiliac distraction test to exclude sacroiliac joint pain
Key exclusion criteria (10 listed)
- Acute severe low back pain
- Patients with hamstring injury
- Active tumor or infection
- Fractures of cervical and lumbar spine
- History of previous lumbar, hip and knee 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 |
|---|---|---|
| Sub occipital muscle inhibition technique and conventional therapyPatient is in supine position Therapist sits near the head of the participant and places his hand below the head of the participant With the pads of hand therapist palpates the arch of atlas between the occipital protuberance and spinous process of axis and place the middle and ring finger over it by flexing the metacarpophalangeal joint in 90 degrees of flexion, base of skull will rest on hands Pressure is exerted in upward direction towards the therapist and is maintained for two minutes so that the muscle scan relax Participants are guided to keep their eyes close in order to avoid movement which affects the tone of sub occipital muscle | Other | Sub occipital muscle inhibition technique along with conventional therapy |
| conventional therapyTranscutaneous electrical nerve stimulation at lower back and hamstring muscles (pulse rate: 4Hertz, pulse duration: 150µs for 15mins) Hot pack ( 15mins),Ankle pumps (15 reps with 5 sec hold), Knee Range of motions (flexion and extension,10 reps),Quadriceps set (10 reps,5 sec hold),Vastus Medialis oblique (10 reps 5 sec hold),Gluteus sets (10 reps, 5 sec hold),Single knee to chest (10 reps with 10 sec hold) McKenzie exercises (10 reps with 10 sec hold and 10 sec rest),Stretching of calf and hamstring muscles (passive stretching,7 reps with 5 sec hold). | Other | conventional therapy |
Primary outcome
Active knee extension test:
Time frame: two weeks
Active knee extension test is performed for assessing the flexibility of hamstring muscles. The test is performed by positioning the participant in supine position, hip is placed at 90 degrees of flexion while opposite leg is stabilized in order to avoid hip flexion. The lumbar spine is in neutral position. The fulcrum of goniometer is placed over the lateral condyle of femur, proximal arm of goniometer is placed on the lateral surface of femur keeping the greater trochanter for reference and the distal arm is placed along the lateral surface of fibula with lateral malleolus keeping for reference. The participant is then asked to actively extend the knee till the point of pain or maximum tolerable stretch to hamstring muscle, measurements are then recorded from goniometer. its reliability with intra-class correlation coefficient (ICC) of 0.87 for dominant knee and 0.81 for non-dominant knee. .
Numeric Pain Rating Scale (NPRS):
Time frame: two weeks
The Numeric Pain Rating Scale (NPRS) is used to measure the subjective intensity of pain. The NPRS is an eleven-point scale ranging from 0 to 10. In which "0" is for no pain and "10" is for the most intense/worst pain, while the NPRS exhibited moderate reliability (ICC = 0.27-0.84)
Inclinometer for range of motion
Time frame: two weeks
An inclinometer is a commonly used device in physiotherapy to measure angles and the range of motion (ROM) of joints.it consists of a sensor which is sensitive to gravity and measures the angles, angle is then displayed on a digital display or a dial. The angle of the inclinometer will change as the joint moves. The maximum angle reached is the ROM of the joint. Inter-rater reliability of inclinometer is ICCs 0.71-0.87.
Oswestry disability index questionnaire (ODI):
Time frame: two weeks
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researcher use to measure a patient\'s permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Questionnaire examines the level of disability in 10 everyday activities of daily living which includes pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social interaction, travel, employment/ homemaking. Each item consists of 6 statements which are scored from 0-5, 0 indicating least disability and 5 indicates the greatest, total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability. Test-retest reliability was consistently high across studies (mean ICC value of 0.937 ± 0.032).
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 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Mechanical Low Back Pain
Not yet recruiting
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,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Low Back Pain, Dry Needling
Recruiting
Fusion or Not - a Study on Low Back Pain
Low Back Pain, Mechanical, Degenerative Disc Disease Lumbar
Recruiting
Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
Low Back Pain, Mechanical, Lower Cross Syndrome
RecruitingPhase 1
Adia Med of Winter Park LLC Lower Back Pain Research Study
Chronic Mechanical Lower Back Pain, Lower Back Pain
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.
maria Khalid, MSOMPT 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?
A study testing Sub occipital muscle inhibition technique and conventional therapy and conventional therapy in people with Mechanical Low Back Pain, run by Riphah International University 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 3 inclusion and 10 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 23 Jul 2024. 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?
Active knee extension test: (time frame: two 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?
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 23 Jul 2024.