Chronic Low Back PainNCT07291934
Pilates and Resistance Training for Pain, Disability, and Sleep in Chronic Low Back Pain
A study testing Combined Intervention (Pilates + Resistance Training) and Pilates in people with Chronic Low Back Pain, run by Al-Azhar University at 1 site in Palestinian Territories.
Trial summary
This study will investigate the effect of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances. Participants will be randomly assigned into three groups: Combined intervention group: Pilates plus resistance training Single intervention… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Combined Intervention (Pilates + Resistance Training) and Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 5 Oct 2025to 17 Sep 2026
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically diagnosed with chronic low back pain (CLBP), defined as pain localized between the lower rib margin and gluteal folds, lasting ≥12 weeks.
- Sleep Quality: Poor sleep quality, defined as PSQI global score >5.
Who cannot join
- Specific LBP causes: Low back pain due to fractures, tumors, infections, inflammatory disorders, or systemic disease.
- Recent spinal surgery: History of lumbar spine surgery within the past 12 months.
- Severe comorbidities: Serious cardiovascular, respiratory, neurological, or musculoskeletal disorders that contraindicate exercise.
- Pregnancy or planned pregnancy during the study period.
- Current participation in structured exercise programs targeting the back (Pilates, resistance training, or core stabilization) within the last 3 months.
- Use of sleep medications or interventions that cannot be maintained stable during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pilates and Resistance Training on Pain, Disability, and Sleep Quality in Patients With Chronic Low Back Pain and Sleep Disturbances
This study will investigate the effect of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances. Participants will be randomly assigned into three groups:
Combined intervention group: Pilates plus resistance training
Read more
Single intervention group: Pilates alone
Control group: Advices only
All interventions will be delivered 3 times per week for 8 weeks, with outcome measures assessed at baseline, post-intervention (8 weeks), and follow-up (16 weeks). It is expected that the combined intervention group will show the greatest improvements in pain, disability, and sleep quality, while the single intervention group will demonstrate moderate benefits compared with usual care.
Read the detailed description
This study will investigate the effects of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances in the Gaza Strip. The study will use a 3-arm randomized controlled trial design, with participants randomly assigned to one of three groups:
Combined Intervention Group: Pilates plus resistance training
Single Intervention Group: Pilates or resistance training alone
Control Group: Usual care
The intervention groups will participate in 2 supervised sessions per week for 8 weeks. The control group will continue their usual care without structured or supervisedexercise.
Outcome measures will be assessed at baseline, post-intervention (8 weeks), and follow-up (16 weeks). The outcomes include pain intensity and disability, while sleep quality.
The study aims to determine whether the combined exercise intervention produces greater improvements than a single exercise intervention or usual care, providing evidence for the most effective rehabilitation strategy for patients with chronic low back pain and sleep disturbances.
- Conditions
- Chronic Low Back Pain
- Being tested
- Combined Intervention (Pilates + Resistance Training), Pilates, Control (Usual Care)
- Keywords
- sleep, chronic low back pain, disability, Pilate, Resistance traning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Intervention (Pilates + Resistance Training)Other
Participants will receive both Pilates and resistance training exercises, supervised 2 times per week for 8 weeks. This intervention aims to evaluate the combined effect on improving pain, disability, and sleep quality.
PilatesOther
Participants will perform Pilates exercises only, supervised 2 times per week for 8 weeks. This intervention will assess the effectiveness of Pilates alone on the study outcomes.
Control (Usual Care)Other
Participants will continue their routine care without structured exercise. This intervention serves as a baseline comparison to determine the effects of the exercise programs beyond standard care.
| Study group | Role | What they receive |
|---|---|---|
| Combined Intervention Group (Pilates + Resistance Training): | Experimental | Participants in this group will receive both Pilates and resistance training exercises. The program will be supervised 2 times per week for 8 weeks.This arm is designed to evaluate the synergistic effect of the combined interventions on pain, disability, and sleep quality. Receives: Other: Combined Intervention (Pilates + Resistance Training) |
| Pilates Group | Experimental | Participants will perform Pilates exercises only under supervision 2 times per week for 8 weeks, with optional home practice. This arm will assess the effectiveness of Pilates alone on the study outcomes. Receives: Other: Pilates |
| Control Group (Usual Care): | Other | Participants in the control group will continue their routine care without structured or supervised exercise. This group will serve as a baseline comparison to determine the effects of the interventions beyond standard care. Receives: Other: Control (Usual Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity:
Measured using the Visual Analog Scale (VAS), a 10-cm line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." It captures the patient's perceived pain severity.
Measured: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)
Disability
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a widely used, validated questionnaire that assesses functional disability in individuals with low back pain. It measures the impact of back pain on a person's ability to perform activities of daily living (ADL) and overall functional limitations.
Structure:
The ODI contains 10 sections, each focusing on a different aspect of daily function:
Pain intensity
Personal care (washing, dressing)
Lifting
Walking
Sitting
Standing
Sleeping
Social life
Traveling
Employment/homemaking
Each section has 6 statements scored from 0 to 5, with higher scores indicating greater disability.
Measured: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)
Sleep_ Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported questionnaire used to assess sleep quality and disturbances over the past month. It is widely used in clinical and research settings, including studies on chronic pain and musculoskeletal disorders.
Structure:
The PSQI consists of 19 individual items combined into 7 components:
Subjective sleep quality - the individual's perception of their sleep
Sleep latency - time taken to fall asleep
Sleep duration - total hours of sleep per night
Habitual sleep efficiency - percentage of time in bed actually spent sleeping
Sleep disturbances - factors causing sleep interruptions (e.g., waking up, pain, environmental disturbances)
Use of sleep medication - frequency of taking sleep aids
Daytime dysfunction - difficulty staying awake or maintaining function during the day
Scoring:
Each component is scored from 0 (no difficulty) to 3 (severe difficulty).
The component scores are summed to generate a global PSQI score
Measured: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start5 Oct 2025
- Primary completion17 Sep 2026
- Study completion17 Sep 2026
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.
- More trials run by Al-Azhar 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mosab ALdabbas, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291934
- Sponsor's protocol ID
- ALAZHAR UNIVERSITY in Gaza
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2025
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates and Resistance Training on Pain, Disability, and Sleep Quality in Patients With Chronic Low Back Pain and Sleep Disturbances
- ClinicalTrials.gov ID
- NCT07291934
- Acronym / sponsor ID
- ALAZHAR UNIVERSITY in Gaza
- Conditions
- Chronic Low Back Pain
- Keywords
- sleep, chronic low back pain, disability, Pilate, Resistance traning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 18 Dec 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.
This study will investigate the effect of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances. Participants will be randomly assigned into three groups:
Combined intervention group: Pilates plus resistance training
Single intervention group: Pilates alone
Control group: Advices only
All interventions will be delivered 3 times per week for 8 weeks, with outcome measures assessed at baseline, post-intervention (8 weeks), and follow-up (16 weeks). It is expected that the combined intervention group will show the greatest improvements in pain, disability, and sleep quality, while the single intervention group will demonstrate moderate benefits compared with usual care.
Detailed description
This study will investigate the effects of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances in the Gaza Strip. The study will use a 3-arm randomized controlled trial design, with participants randomly assigned to one of three groups:
Combined Intervention Group: Pilates plus resistance training
Single Intervention Group: Pilates or resistance training alone
Control Group: Usual care
The intervention groups will participate in 2 supervised sessions per week for 8 weeks. The control group will continue their usual care without structured or supervisedexercise.
Outcome measures will be assessed at baseline, post-intervention (8 weeks), and follow-up (16 weeks). The outcomes include pain intensity and disability, while sleep quality.
The study aims to determine whether the combined exercise intervention produces greater improvements than a single exercise intervention or usual care, providing evidence for the most effective rehabilitation strategy for patients with chronic low back pain and sleep disturbances.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined Intervention Group (Pilates + Resistance Training): | Experimental | Other: Combined Intervention (Pilates + Resistance Training)Participants in this group will receive both Pilates and resistance training exercises. The program will be supervised 2 times per week for 8 weeks.This arm is designed to evaluate the synergistic effect of the combined interventions on pain, disability, and sleep quality. |
| Pilates Group | Experimental | Other: PilatesParticipants will perform Pilates exercises only under supervision 2 times per week for 8 weeks, with optional home practice. This arm will assess the effectiveness of Pilates alone on the study outcomes. |
| Control Group (Usual Care): | Other | Other: Control (Usual Care)Participants in the control group will continue their routine care without structured or supervised exercise. This group will serve as a baseline comparison to determine the effects of the interventions beyond standard care. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinically diagnosed with chronic low back pain (CLBP), defined as pain localized between the lower rib margin and gluteal folds, lasting ≥12 weeks.
- Sleep Quality: Poor sleep quality, defined as PSQI global score >5.
Key exclusion criteria (6 listed)
- Specific LBP causes: Low back pain due to fractures, tumors, infections, inflammatory disorders, or systemic disease.
- Recent spinal surgery: History of lumbar spine surgery within the past 12 months.
- Severe comorbidities: Serious cardiovascular, respiratory, neurological, or musculoskeletal disorders that contraindicate exercise.
- Pregnancy or planned pregnancy during the study period.
- Current participation in structured exercise programs targeting the back (Pilates, resistance training, or core stabilization) within the last 3 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 |
|---|---|---|
| Combined Intervention (Pilates + Resistance Training)Participants will receive both Pilates and resistance training exercises, supervised 2 times per week for 8 weeks. This intervention aims to evaluate the combined effect on improving pain, disability, and sleep quality. | Other | Combined Intervention Group (Pilates + Resistance Training): |
| PilatesParticipants will perform Pilates exercises only, supervised 2 times per week for 8 weeks. This intervention will assess the effectiveness of Pilates alone on the study outcomes. | Other | Pilates Group |
| Control (Usual Care)Participants will continue their routine care without structured exercise. This intervention serves as a baseline comparison to determine the effects of the exercise programs beyond standard care. | Other | Control Group (Usual Care): |
Primary outcome
Pain Intensity:
Time frame: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)
Measured using the Visual Analog Scale (VAS), a 10-cm line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." It captures the patient's perceived pain severity.
Disability
Time frame: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)
Oswestry Disability Index (ODI) The Oswestry Disability Index (ODI) is a widely used, validated questionnaire that assesses functional disability in individuals with low back pain. It measures the impact of back pain on a person's ability to perform activities of daily living (ADL) and overall functional limitations. Structure: The ODI contains 10 sections, each focusing on a different aspect of daily function: Pain intensity Personal care (washing, dressing) Lifting Walking Sitting Standing Sleeping Social life Traveling Employment/homemaking Each section has 6 statements scored from 0 to 5, with higher scores indicating greater disability.
Sleep_ Pittsburgh Sleep Quality Index (PSQI)
Time frame: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)
The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported questionnaire used to assess sleep quality and disturbances over the past month. It is widely used in clinical and research settings, including studies on chronic pain and musculoskeletal disorders. Structure: The PSQI consists of 19 individual items combined into 7 components: Subjective sleep quality - the individual's perception of their sleep Sleep latency - time taken to fall asleep Sleep duration - total hours of sleep per night Habitual sleep efficiency - percentage of time in bed actually spent sleeping Sleep disturbances - factors causing sleep interruptions (e.g., waking up, pain, environmental disturbances) Use of sleep medication - frequency of taking sleep aids Daytime dysfunction - difficulty staying awake or maintaining function during the day Scoring: Each component is scored from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to generate a global PSQI score
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 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Intervention (Pilates + Resistance Training) and Pilates in people with Chronic Low Back Pain, run by Al-Azhar University at 1 site in Palestinian Territories.
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 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 21 Sep 2026. 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 Palestinian Territories. 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: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 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 21 Sep 2026.