Chronic Low-back PainNCT05779748
The Effect of an Acute Bout of Exercise on Pain Sensitivity and Clinical Pain in Adults With Chronic Low Back Pain
A study testing Single bout of exercise in people with Chronic Low-back Pain, run by Taif University at 1 site in Saudi Arabia.
Trial summary
The goal of this interventional study is to investigate the efficacy of an acute bout of exercises on pain sensitivity (primary aim) and clinical pain intensity (secondary aim) among adults with Chronic Low Back Pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Single bout of exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Mar 2023to 5 Aug 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years or older; and
- diagnosed with chronic non-specific LBP (lasting for more than 12 weeks).
- Able to perform physical therapy exercises.
Who cannot join
- pregnancy.
- patients who have neurological compromise (e.g., cauda equine syndrome or spinal nerve compromise).
- Patients who have spinal pathologies (e.g., fracture, ankylosing spondylitis)
- Uncontrolled diabetic.
- who has any history of heart disease (e.g., myocardial infarction, embolism)
- Orthopaedic impairment (e.g., balance problems)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this interventional study is to investigate the efficacy of an acute bout of exercises on pain sensitivity (primary aim) and clinical pain intensity (secondary aim) among adults with Chronic Low Back Pain. The following question will be answered in this research Q1: Is acute bout of exercise effective in reducing pain among adults with Chronic Low Back Pain?
Participants who agree to participate and sign the informed consent will be randomized to one of three groups:
Read more
Group 1: Isometric exercise with neutral language and no verbal suggestion consisting of 1 rep of wall squat, 3 min or to volitional fatigue at 100° knee angle;(n=30).
Group 2: Isometric exercise with neutral language and no verbal suggestion consisting of 3 reps of wall squat, 3 min or to volitional fatigue at 100°degree knee angle, 30-sec rest between rep, ;(n=30).
Group 3 (Control group): true control (do nothing);(n=30).
- Conditions
- Chronic Low-back Pain
- Being tested
- Single bout of exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single bout of exerciseOther
isometric wall squat at a knee joint angle of 100 degrees. Instruct participant to place their back against the wall with feet positioned parallel and spaced shoulder-width apart. Lower themselves down until they reached a knee joint angle of 100 degrees. Measure knee joint angle by placing a goniometer on the lateral epicondyle of the knee, in line with the femur whilst the anchor arm was in line with the lateral malleolus.
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercise-one repetition | Experimental | Isometric exercise consisting of 1 session only. The session will last for around 5 minutes which will include asking the patient to do 1 repetition of wall squat for 3 min or to volitional fatigue at 100° knee angle.
Intervention: Other: Single bout of exercise Receives: Other: Single bout of exercise |
| Isometric exercise-three repetitions | Experimental | isometric exercise consisting of 1 session only. The session will last for around 10 minutes which will include asking the patient to perform 3 repetitions of wall squats (each time the exercise will be performed for 3 min or to volitional fatigue at 100°degree knee angle); the patient will be given 30-sec rest between repetitions.
Intervention: Other: Single bout of exercise Receives: Other: Single bout of exercise |
| Control | No intervention | Will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
The pain will be measured using digital pressure algometer, FDX®️ (Wagner instrument, Greenwich, USA). All trials will be conducted on forearm, lumbar spine and calf sites. There will be at least 20 sec rest before an individual site is tested again. Two trials will be performed at each site. The raw values of each test will be recorded.
Because we are testing repeated times, we will use a marker to mark the location of each test site to ensure consistency in location.
Algometer must be positioned perpendicular to the measurement site for all trials.
Measured: [ Time Frame: Change from pre-intervention (baseline) compared to post-intervention (immediately after session) ]
Secondary outcomes (1)
Pain intensity
It will be assessed using Visual Analogue Scale (VAS; 0-10). A rating of zero means that participant don't currently have pain at the low back. A rating of ten on this scale means that the pain at low back is the worst pain. So, the higher the number on this scale means the higher the pain intensity participant is experiencing.
Measured: [ Time Frame: Change from pre-intervention (baseline) compared to post-intervention (immediately after session) ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start15 Mar 2023
- Primary completion5 Jun 2023
- Study completion5 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taif University
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdullah Hospital
- Responsible party
- Principal investigator, Hosam Alzahrani, Taif University
- Investigators
- Hossam Alzahrani, PhD, Principal investigator, Taif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779748
- Sponsor's protocol ID
- BIS-23-00007-11012023
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 5 Aug 2025
- 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Acute Bout of Exercise on Pain Sensitivity and Clinical Pain in Adults With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05779748
- Acronym / sponsor ID
- BIS-23-00007-11012023
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Taif UniversityUniversity, hospital or other
- Collaborators
- King Abdullah Hospital
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Aug 2023 (actual)
- First posted
- 22 Mar 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 goal of this interventional study is to investigate the efficacy of an acute bout of exercises on pain sensitivity (primary aim) and clinical pain intensity (secondary aim) among adults with Chronic Low Back Pain. The following question will be answered in this research Q1: Is acute bout of exercise effective in reducing pain among adults with Chronic Low Back Pain?
Participants who agree to participate and sign the informed consent will be randomized to one of three groups:
Group 1: Isometric exercise with neutral language and no verbal suggestion consisting of 1 rep of wall squat, 3 min or to volitional fatigue at 100° knee angle;(n=30).
Group 2: Isometric exercise with neutral language and no verbal suggestion consisting of 3 reps of wall squat, 3 min or to volitional fatigue at 100°degree knee angle, 30-sec rest between rep, ;(n=30).
Group 3 (Control group): true control (do nothing);(n=30).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isometric exercise-one repetition | Experimental | Other: Single bout of exerciseIsometric exercise consisting of 1 session only. The session will last for around 5 minutes which will include asking the patient to do 1 repetition of wall squat for 3 min or to volitional fatigue at 100° knee angle. Intervention: Other: Single bout of exercise |
| Isometric exercise-three repetitions | Experimental | Other: Single bout of exerciseisometric exercise consisting of 1 session only. The session will last for around 10 minutes which will include asking the patient to perform 3 repetitions of wall squats (each time the exercise will be performed for 3 min or to volitional fatigue at 100°degree knee angle); the patient will be given 30-sec rest between repetitions. Intervention: Other: Single bout of exercise |
| Control | No intervention | –Will not receive any intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years or older; and
- diagnosed with chronic non-specific LBP (lasting for more than 12 weeks).
- Able to perform physical therapy exercises.
Key exclusion criteria (6 listed)
- pregnancy.
- patients who have neurological compromise (e.g., cauda equine syndrome or spinal nerve compromise).
- Patients who have spinal pathologies (e.g., fracture, ankylosing spondylitis)
- Uncontrolled diabetic.
- who has any history of heart disease (e.g., myocardial infarction, embolism)
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 |
|---|---|---|
| Single bout of exerciseisometric wall squat at a knee joint angle of 100 degrees. Instruct participant to place their back against the wall with feet positioned parallel and spaced shoulder-width apart. Lower themselves down until they reached a knee joint angle of 100 degrees. Measure knee joint angle by placing a goniometer on the lateral epicondyle of the knee, in line with the femur whilst the anchor arm was in line with the lateral malleolus. | Other | Isometric exercise-one repetition, Isometric exercise-three repetitions |
Primary outcome
Pain pressure threshold
Time frame: [ Time Frame: Change from pre-intervention (baseline) compared to post-intervention (immediately after session) ]
The pain will be measured using digital pressure algometer, FDX®️ (Wagner instrument, Greenwich, USA). All trials will be conducted on forearm, lumbar spine and calf sites. There will be at least 20 sec rest before an individual site is tested again. Two trials will be performed at each site. The raw values of each test will be recorded. Because we are testing repeated times, we will use a marker to mark the location of each test site to ensure consistency in location. Algometer must be positioned perpendicular to the measurement site for all trials.
1 secondary outcome
Pain intensity
Time frame: [ Time Frame: Change from pre-intervention (baseline) compared to post-intervention (immediately after session) ]
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 5 Aug 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. This study is not recruiting at the moment.
Hossam Alzahrani, PhD principal investigator
Taif 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 Single bout of exercise in people with Chronic Low-back Pain, 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 3 inclusion and 6 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 5 Aug 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?
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 pressure threshold (time frame: [ Time Frame: Change from pre-intervention (baseline) compared to post-intervention (immediately after session) ]). 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 5 Aug 2025.