Low Back PainNCT06284018
Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain
A study testing Progressive Muscle Relaxation Exercises and Pilates Exercises in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to compare between the effect of progressive muscle relaxation exercises and the effect of pilates exercises on postnatal low back pain Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Progressive Muscle Relaxation Exercises and Pilates Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Feb 2024to 15 Jun 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ages were ranged from 25 to 35 years old and their body mass index (BMI) did not exceed 30kg/m2. They were postnatal by three months. The number of parity of all women was ranged from (1-3) times.
Who cannot join
- previous trauma to the spine, pelvis and lower limbs,
- previous history of spinal surgery (such as spinal fusion surgery, vertebroplasty, or - --kyphoplasty), congenital spinal deformities, history of spinal tumors, ankylosing spondylitis, osteoporosis other spondyloarthritis
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to compare between the effect of progressive muscle relaxation exercises and the effect of pilates exercises on postnatal low back pain
Read the detailed description
Ethical approval was obtained from the Institutional Review Board of the Faculty of Physical Therapy, Cairo University, before starting this study [No: P.T.REC/012/003885]. The study's protocol was explained in detail to each woman who signed an informed consent form before starting this study. This work adhered to the principles outlined in the Declaration of Helsinki for the ethical conduct of research involving human subjects. It was carried out from June till September 2023
Sample Size Calculation:
Based on a pilot study, sample size was calculated according to the significant difference in the value of mean difference (pretreatments - post treatment values) of pain pressure algometer between progressive muscle relaxation exercises (2.01 ± 0.39) and pilates exercises (2.90 ± 0.24) groups in unpaired t test, with α=0.05, power of 80%, and an effect size of 0.74. So a sample size of 30 patients/per group would be required and increased to 35 women to allow for a 15% dropout rate (GPower 301 http:www.psycho.uni-duesseldorf.de) Randomization of sample selection was achieved using closed envelop way. Classification of the sample by simple random way into two groups equal in number, by using sixty closed envelop, each thirty envelop contained a name of a group from the two groups (Group A) or (Group B) and asking each woman to choose one envelop from them, each woman attended to the group according the name of the group written in her envelop. After randomization, they were divided into two groups equal in number
- Conditions
- Low Back Pain
- Being tested
- Progressive Muscle Relaxation Exercises, Pilates Exercises
- Keywords
- Progressive muscle relaxation exercises, Pilate's exercises, Low back pain., post natal period, relaxation exercises
- 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.
Progressive Muscle Relaxation ExercisesOther
- Focus on the targeted muscle group.
- Take a slow, deep breath while squeezing on muscle group as hard as she can (not to the point of strain). Keep the muscle tensed for 5 seconds.
Hands and arms, forehead ,Eyes and Cheek, Mouth and Jaw , Neck and Shoulder ,Stomach , Leg and Toes
Pilates ExercisesOther
Pilates exercise program consisted of floor exercises on a rubber mat, including the following exercises: a- Pelvic Curl. b- Single-Leg Lift. c- Chest Lift. d- Supine Spine Twist. e- Basic Back Extension.
| Study group | Role | What they receive |
|---|---|---|
| intervention group1 | Experimental | Group A consisted of thirty postnatal women. They were treated by progressive muscle relaxation exercises three times per week for 4 weeks. Receives: Other: Progressive Muscle Relaxation Exercises |
| intervention group 2 | Experimental | Group B consisted of thirty postnatal women. They were treated by pilates exercises three times per week for 4 weeks. Receives: Other: Pilates Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Algometer
Assessment of pressure pain thresholds is a valid and reliable clinical tool to evaluate the subjective perception of pain in response to application of pressure in low back pain patient. Pressure algometry is used in manual therapy to objectively quantify the pressure pain thresholds and it was shown that a predictable variation exists across various spinal levels from cervical to lumbar levels. The examiner determined the main 4 points of assessment (5 cm lateral to the spinous process of L3 and L5 bilaterally), the force of PA was gradually increased at a rate of 1 kg/s, by silently counting seconds while increasing pressure, then the patient was asked to tell the examiner when the pressure became painful while the examiner applied the pressure on the assessment points
Measured: period of treatment was 4 weeks
Secondary outcomes (1)
Oswestry Disability Index
ODI (P) is a reliable and valid instrument for measurement of disability related to low back pain in Punjabi population. It can be used both in research and clinical care settings in future Sandal, D., [12] . The 10 factors which constitute the ODI criteria for assessing patients' functional impairment are pain intensity, ease of personal care, lifting, working, sitting, standing, sleeping, sex life, social life and travelling. Each of the 10 questions was scored from 0 to 5, giving a maximum score of 50. The total score is then converted into a percentage by multiplying it by 2. Scores are stratified into severity:
- 0-4: No disability
- 5-14: Mild disability
- 15-24: Moderate disability
- 25-34: Severe disability
- 35-50: Completely disabled
Measured: period of treatment was 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start24 Feb 2024
- Primary completion30 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- intervention The design of the study was randomized controlled study. The patients were divided randomly into two equal groups (A\&B). Group A consisted of thirty postnatal women. They were treated by progressive muscle relaxation exercises three times per week for 4 weeks. Group B consisted of thirty postnatal women. They were treated by pilates exercises three times per week for 4 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Ahmed Safy Eldeen Mahmoud, Cairo University
- Investigators
- Hala M Emara, phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284018
- Sponsor's protocol ID
- postnatal low back pain
- Status last verified
- Jun 2024
- First submitted
- 21 Feb 2024
- Last updated
- 1 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain
- ClinicalTrials.gov ID
- NCT06284018
- Acronym / sponsor ID
- postnatal low back pain
- Conditions
- Low Back Pain
- Keywords
- Progressive muscle relaxation exercises, Pilate's exercises, Low back pain., post natal period, relaxation exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 28 Feb 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.
This study was conducted to compare between the effect of progressive muscle relaxation exercises and the effect of pilates exercises on postnatal low back pain
Detailed description
Ethical approval was obtained from the Institutional Review Board of the Faculty of Physical Therapy, Cairo University, before starting this study [No: P.T.REC/012/003885]. The study's protocol was explained in detail to each woman who signed an informed consent form before starting this study. This work adhered to the principles outlined in the Declaration of Helsinki for the ethical conduct of research involving human subjects. It was carried out from June till September 2023
Sample Size Calculation:
Based on a pilot study, sample size was calculated according to the significant difference in the value of mean difference (pretreatments - post treatment values) of pain pressure algometer between progressive muscle relaxation exercises (2.01 ± 0.39) and pilates exercises (2.90 ± 0.24) groups in unpaired t test, with α=0.05, power of 80%, and an effect size of 0.74. So a sample size of 30 patients/per group would be required and increased to 35 women to allow for a 15% dropout rate (GPower 301 http:www.psycho.uni-duesseldorf.de) Randomization of sample selection was achieved using closed envelop way. Classification of the sample by simple random way into two groups equal in number, by using sixty closed envelop, each thirty envelop contained a name of a group from the two groups (Group A) or (Group B) and asking each woman to choose one envelop from them, each woman attended to the group according the name of the group written in her envelop. After randomization, they were divided into two groups equal in number
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- intervention The design of the study was randomized controlled study. The patients were divided randomly into two equal groups (A\&B). Group A consisted of thirty postnatal women. They were treated by progressive muscle relaxation exercises three times per week for 4 weeks. Group B consisted of thirty postnatal women. They were treated by pilates exercises three times per week for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| intervention group1 | Experimental | Other: Progressive Muscle Relaxation ExercisesGroup A consisted of thirty postnatal women. They were treated by progressive muscle relaxation exercises three times per week for 4 weeks. |
| intervention group 2 | Experimental | Other: Pilates ExercisesGroup B consisted of thirty postnatal women. They were treated by pilates exercises three times per week for 4 weeks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ages were ranged from 25 to 35 years old and their body mass index (BMI) did not exceed 30kg/m2. They were postnatal by three months. The number of parity of all women was ranged from (1-3) times.
Key exclusion criteria (2 listed)
- previous trauma to the spine, pelvis and lower limbs,
- previous history of spinal surgery (such as spinal fusion surgery, vertebroplasty, or - --kyphoplasty), congenital spinal deformities, history of spinal tumors, ankylosing spondylitis, osteoporosis other spondyloarthritis
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 |
|---|---|---|
| Progressive Muscle Relaxation Exercises* Focus on the targeted muscle group. * Take a slow, deep breath while squeezing on muscle group as hard as she can (not to the point of strain). Keep the muscle tensed for 5 seconds. Hands and arms, forehead ,Eyes and Cheek, Mouth and Jaw , Neck and Shoulder ,Stomach , Leg and Toes | Other | intervention group1 |
| Pilates ExercisesPilates exercise program consisted of floor exercises on a rubber mat, including the following exercises: a- Pelvic Curl. b- Single-Leg Lift. c- Chest Lift. d- Supine Spine Twist. e- Basic Back Extension. | Other | intervention group 2 |
Primary outcome
Pressure Algometer
Time frame: period of treatment was 4 weeks
Assessment of pressure pain thresholds is a valid and reliable clinical tool to evaluate the subjective perception of pain in response to application of pressure in low back pain patient. Pressure algometry is used in manual therapy to objectively quantify the pressure pain thresholds and it was shown that a predictable variation exists across various spinal levels from cervical to lumbar levels. The examiner determined the main 4 points of assessment (5 cm lateral to the spinous process of L3 and L5 bilaterally), the force of PA was gradually increased at a rate of 1 kg/s, by silently counting seconds while increasing pressure, then the patient was asked to tell the examiner when the pressure became painful while the examiner applied the pressure on the assessment points
1 secondary outcome
Oswestry Disability Index
Time frame: period of treatment was 4 weeks
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 1 Jul 2024.
- 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.
Hala M Emara, phd study director
Cairo 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 Progressive Muscle Relaxation Exercises and Pilates Exercises in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 2 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 1 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 Egypt. 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?
Pressure Algometer (time frame: period of treatment was 4 weeks). 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 1 Jul 2024.