Chronic Low Back Pain (CLBP)NCT06963658
Acute Effect of Isometric Excercise on Pain Sensitivity in Adults With Chronic Low Back Pain
A study testing Multiple repetition isometric wall squat and Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold in people with Chronic Low Back Pain (CLBP), run by Taif University at 1 site in Saudi Arabia.
Trial summary
Randomized control trial to examine the immediate effect of isometric exercise on pressure pain threshold (PPT) in adults with chronic low back pain. The secondary aim of this study was to investigate the acute effects of isometric exercise on clinical pain intensity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Multiple repetition isometric wall squat and Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants aged ≥18 years or older
- participant diagnosed with non-specific chronic lower back pain (> 12 weeks)
- Able to perform physical therapy excercise . Exclusion criteria : The study will exclude
- 1- pregnant women 2- lactating women for one or less than one year post-natal. 3- any certain medical conditions that could interfere with physical activity, including:
- uncontrolled diabetes
- cardiovascular problem
Show all 14Show fewer
- orthopedic impairments
- balance problems. 4-serious spinal pathologies :
- infection
- fractures
- tumors
- inflammatory diseases like ankylosing spondylitis 5- neurological compromise,
- spinal nerve compromise
- cauda equina syndrome
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdullah Hospital in bisha
Bisha, 'Asir Region, 67714
Asma A Alqahtani, B.S.C, 966504435372, Alqahtaniasma61@gmail.com
Hosam A Alzahrani, PHD, 966550668282, halzahrani@tu.edu.sa
About this study
Randomized control trial to examine the immediate effect of isometric exercise on pressure pain threshold (PPT) in adults with chronic low back pain. The secondary aim of this study was to investigate the acute effects of isometric exercise on clinical pain intensity.
Read the detailed description
Participants will attend a single visit to the hospital for two hours, which will include collecting demographic details and clinical characteristics through self-reported assessment scales. After that, outcome measures (pain sensitivity and current low back pain intensity) were collected prior to the intervention and repeated immediately post-intervention.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Multiple repetition isometric wall squat, Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold, Control quiet seated rest
- Keywords
- pain sensitivity, isometric exercise, low back pain
- 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.
Multiple repetition isometric wall squatOther
Participants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold.
Multiple Isometric wall squat exercise + Double Leg Lower with Isometric HoldOther
Participants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold. Immediately post 60 second rest, Determine the participant's maximum angle using the double leg lowering test from supine position let the participant with both legs straightened before lifting the posterior hip, lowering the legs to a specific angle. Turn on the stopwatch. Hold the position near--maximally, try to achieve on (IES=9/10) and hold for the longest duration. They should reach 4 minutes for 3 repetition with 30 seconds rest between repetition
Control quiet seated restOther
The control group served as the control group and did not perform any exercise. Participants were instructed to sit quietly in a standard height stationary clinical room patient chair for the entire eight minutes.
| Study group | Role | What they receive |
|---|---|---|
| Multiple repetition isometric wall squat | Experimental | Participants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold. Receives: Other: Multiple repetition isometric wall squat |
| Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold | Experimental | Participants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold.
Immediately post 60 second rest, Determine the participant's maximum angle using the double leg lowering test from supine position let the participant with both legs straightened before lifting the posterior hip, lowering the legs to a specific angle. Turn on the stopwatch. Hold the position near--maximally, try to achieve on (IES=9/10) and hold for the longest duration. They should reach 4 minutes for 3 repetition with 30 seconds rest between repetition Receives: Other: Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold |
| Control quiet seated rest | Experimental | The CON group served as the control group and did not perform any exercise. Participants were instructed to sit quietly in a standard height stationary clinical room patient chair for the entire eight minutes. Receives: Other: Control quiet seated rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is pain sensitivity
Pain sensitivity was assessed via pressure pain threshold (PPT) using a standard procedure. The PPT was assessed by a digital pressure algometer (Wagner digital force Ten FDX 25 with 1 cm 2 rubber tip).This instrument has been widely utilized in various studies and has been shown to be valid and reliable in assessing PPT among people with musculoskeletal pain. If post intervention PPT was higher than pre-intervention value, this indicated that pain sensitivity decreased, suggesting exercise induced hypoalgesia occurred. If post-intervention PPT was lower than pre-intervention PPT, this indicates that pain sensitivity increased, suggesting that exercise induced hyperalgesia occurred.
Measured: pre- and immediately post-intervention
Secondary outcomes (1)
The secondary outcome is the pain intensity in the lower back
It is a subjective rating of pain intensity in the lower back using a visual analog scale,where a rating of zero indicates that participant don't have pain and a rating of 10 indicates that the most severe pain. The VAS is reliable and valid for measuring pain in individuals with chronic musculoskeletal conditions. A change of one point in pain intensity on this scale is regarded as the minimal clinically important difference.
Measured: pre- and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Aug 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies 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
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Alzahrani, Taif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963658
- Sponsor's protocol ID
- ISO-Ex 0011112222
- Status last verified
- Aug 2025
- First submitted
- 13 Mar 2025
- Last updated
- 4 Sep 2025
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Isometric Excercise on Pain Sensitivity in Adults With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06963658
- Acronym / sponsor ID
- ISO-Ex 0011112222
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- pain sensitivity, isometric exercise, low back pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taif UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 May 2025 (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.
Randomized control trial to examine the immediate effect of isometric exercise on pressure pain threshold (PPT) in adults with chronic low back pain. The secondary aim of this study was to investigate the acute effects of isometric exercise on clinical pain intensity.
Detailed description
Participants will attend a single visit to the hospital for two hours, which will include collecting demographic details and clinical characteristics through self-reported assessment scales. After that, outcome measures (pain sensitivity and current low back pain intensity) were collected prior to the intervention and repeated immediately post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple repetition isometric wall squat | Experimental | Other: Multiple repetition isometric wall squatParticipants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold. |
| Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold | Experimental | Other: Multiple Isometric wall squat exercise + Double Leg Lower with Isometric HoldParticipants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold. Immediately post 60 second rest, Determine the participant's maximum angle using the double leg lowering test from supine position let the participant with both legs straightened before lifting the posterior hip, lowering the legs to a specific angle. Turn on the stopwatch. Hold the position near--maximally, try to achieve on (IES=9/10) and hold for the longest duration. They should reach 4 minutes for 3 repetition with 30 seconds rest between repetition |
| Control quiet seated rest | Experimental | Other: Control quiet seated restThe CON group served as the control group and did not perform any exercise. Participants were instructed to sit quietly in a standard height stationary clinical room patient chair for the entire eight minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- participants aged ≥18 years or older
- participant diagnosed with non-specific chronic lower back pain (> 12 weeks)
- Able to perform physical therapy excercise . Exclusion criteria : The study will exclude
- 1- pregnant women 2- lactating women for one or less than one year post-natal. 3- any certain medical conditions that could interfere with physical activity, including:
- uncontrolled diabetes
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Multiple repetition isometric wall squatParticipants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold. | Other | Multiple repetition isometric wall squat |
| Multiple Isometric wall squat exercise + Double Leg Lower with Isometric HoldParticipants were directed to rest their backs against the wall with shoulder width apart and feet parallel, then descend until they achieve an angle of 100 degrees at knee joint. The knee joint angle was assessed using a goniometer placed on the lateral epicondyle of the knee, aligned with the femur, while the anchor arm was aligned with the lateral malleolus. They were instructed to maintain the isometric hold for up to three minutes, or until volitional fatigue was reached.with a 30-second rest period between each squat hold. Immediately post 60 second rest, Determine the participant's maximum angle using the double leg lowering test from supine position let the participant with both legs straightened before lifting the posterior hip, lowering the legs to a specific angle. Turn on the stopwatch. Hold the position near--maximally, try to achieve on (IES=9/10) and hold for the longest duration. They should reach 4 minutes for 3 repetition with 30 seconds rest between repetition | Other | Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold |
| Control quiet seated restThe control group served as the control group and did not perform any exercise. Participants were instructed to sit quietly in a standard height stationary clinical room patient chair for the entire eight minutes. | Other | Control quiet seated rest |
Primary outcome
The primary outcome is pain sensitivity
Time frame: pre- and immediately post-intervention
Pain sensitivity was assessed via pressure pain threshold (PPT) using a standard procedure. The PPT was assessed by a digital pressure algometer (Wagner digital force Ten FDX 25 with 1 cm 2 rubber tip).This instrument has been widely utilized in various studies and has been shown to be valid and reliable in assessing PPT among people with musculoskeletal pain. If post intervention PPT was higher than pre-intervention value, this indicated that pain sensitivity decreased, suggesting exercise induced hypoalgesia occurred. If post-intervention PPT was lower than pre-intervention PPT, this indicates that pain sensitivity increased, suggesting that exercise induced hyperalgesia occurred.
1 secondary outcome
The secondary outcome is the pain intensity in the lower back
Time frame: pre- and immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple repetition isometric wall squat and Multiple Isometric wall squat exercise + Double Leg Lower with Isometric Hold in people with Chronic Low Back Pain (CLBP), run by Taif University at 1 site in Saudi Arabia.
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 14 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asma A Alqahtani, B.S.C (966504435372, Alqahtaniasma61@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is pain sensitivity (time frame: pre- and immediately post-intervention). 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 4 Sep 2025.