Low Back Pain, ChronicNCT06759675
Comparative Effects of Group Based Exercises with and Without Cognitive Functional Therapy on Clinical Outcomes in Patients with Chronic Low Back Pain
A study testing group based exercise with Cognitive functional therapy and Group based exercise in people with Low Back Pain, Chronic, run by University of Faisalabad.
Trial summary
1.1Research objective The objective of the study is to find the comparative effects of group based exercises with and without cognitive functional therapy on clinical outcomes in patients with chronic low back? 1.2 Hypothesis Null Hypothesis H0= There is no significant difference of clinical outcomes between the… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Low Back Pain, Chronic
- What is being tested?
- group based exercise with Cognitive functional therapy and Group based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to May 2025
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain level equal or more than 3 on NPRS A score of fourteen percent 14% or more on the Oswestry Disability Index (ODI) Low back pain for at least 6months duration
Who cannot join
- Red flags (neoplastic diseases or cancer in the spine, inflammatory diseases, infections, and fractures) Neurological symptoms and psychiatric, rheumatologic, and cardiac diseases Radiculopathy with symptoms Lumbar stenosis Spondylolisthesis History of spinal surgeries Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
1.1Research objective The objective of the study is to find the comparative effects of group based exercises with and without cognitive functional therapy on clinical outcomes in patients with chronic low back? 1.2 Hypothesis Null Hypothesis H0= There is no significant difference of clinical outcomes between the cognitive functional therapy with group exercises and group based exercises only in patients with chronic low back pain.
Alternative Hypothesis H1= There is a significant difference of clinical outcomes between the cognitive functional therapy with group exercises and group based exercises only in patients with chronic low back pain.
Read the detailed description
Background: Low back pain is the problem gradually increasing in both young and older adults. It can be specific and non-specific, the specific low back pain is the pain which arises due to any structural or functional disease like due to any mechanical factors, poor posture, improper way of lifting and bending while non-specific low back pain is the pain which have no any known causes. Cognitive functional therapy and group based exercises both have beneficial effects to reduce LBP. Aims and objectives: The aim of the study will be to find the comparative effects of group based exercises with and without cognitive functional therapy on clinical outcome in patients with chronic low back pain. Methodology: This study will be Randomized controlled trial. The subjects will be selected through Probability Purposive Sampling.Sample will be 40 calculated by the rao-soft with 20 percent chances of drop out. The participants will be taken from Mujahid hospital, Faisal Hospital and Madina teaching hospital. Participants will be assessed by using Oswestry Disability index and Numerical Pain Rating Scale NPRS for low back pain. Participants will be randomly allocated into two groups.One group will be treated with CFT and group based exercises and one with only group exercises. And at the end, data will be analyzed by using Statistical Package for the Social Sciences (SPSS).
- Conditions
- Low Back Pain, Chronic
- Being tested
- group based exercise with Cognitive functional therapy, Group based exercise
- Keywords
- Cognitive Functional therapy, group based exercise, chronic low back
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group based exercise with Cognitive functional therapyOther
- Cognitive functional therapy CFT A cognitive functional therapy is the behavioral approach which is used to treat low back pain. This approach has 3 components Making sense of pain Exposure with control Lifestyle changes
- Group exercises Group exercises will be the exercises that perform on all individuals. It is performed in a group session having 3 components Pain education Exercises Relaxation
Group based exerciseOther
Group exercises Group exercises will be the exercises that perform on all individuals. It is performed in a group session having 3 components Pain education Exercises Relaxation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | group based exercises with Cognitive functional therapy Receives: Other: group based exercise with Cognitive functional therapy |
| Group 2 | Active comparator | group based exercise only Receives: Other: Group based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Numerical pain rating scale used to assess pain level
Measured: Baseline
Secondary outcomes (1)
ODI
Oswestry Disability Index gives information about functional limitation and level of disability due to pain
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, ChronicStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kashaf Zahra, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759675
- Sponsor's protocol ID
- GBE and CFT in chronic LBP
- Status last verified
- Dec 2024
- First submitted
- 28 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because every participants don't want to share and this will be written in the informed consent that their data will not shared
Publications
Oiestad BE. Critically appraised paper: Cognitive functional therapy reduced disability compared with group-based exercise and education for chronic low back pain [synopsis]. J Physiother. 2021 Apr;67(2):141. doi: 10.1016/j.jphys.2021.01.004. Epub 2021 Mar 17. No abstract available.
PubMed 33744183Avila L, da Silva MD, Neves ML, Abreu AR, Fiuza CR, Fukusawa L, de Sa Ferreira A, Meziat-Filho N. Effectiveness of Cognitive Functional Therapy Versus Core Exercises and Manual Therapy in Patients With Chronic Low Back Pain After Spinal Surgery: Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad105. doi: 10.1093/ptj/pzad105.
PubMed 37548608O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.
PubMed 31630089
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Group Based Exercises with and Without Cognitive Functional Therapy on Clinical Outcomes in Patients with Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06759675
- Acronym / sponsor ID
- GBE and CFT in chronic LBP
- Conditions
- Low Back Pain, Chronic
- Keywords
- Cognitive Functional therapy, group based exercise, chronic low back
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 6 Jan 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.
1.1Research objective The objective of the study is to find the comparative effects of group based exercises with and without cognitive functional therapy on clinical outcomes in patients with chronic low back? 1.2 Hypothesis Null Hypothesis H0= There is no significant difference of clinical outcomes between the cognitive functional therapy with group exercises and group based exercises only in patients with chronic low back pain.
Alternative Hypothesis H1= There is a significant difference of clinical outcomes between the cognitive functional therapy with group exercises and group based exercises only in patients with chronic low back pain.
Detailed description
Background: Low back pain is the problem gradually increasing in both young and older adults. It can be specific and non-specific, the specific low back pain is the pain which arises due to any structural or functional disease like due to any mechanical factors, poor posture, improper way of lifting and bending while non-specific low back pain is the pain which have no any known causes. Cognitive functional therapy and group based exercises both have beneficial effects to reduce LBP. Aims and objectives: The aim of the study will be to find the comparative effects of group based exercises with and without cognitive functional therapy on clinical outcome in patients with chronic low back pain. Methodology: This study will be Randomized controlled trial. The subjects will be selected through Probability Purposive Sampling.Sample will be 40 calculated by the rao-soft with 20 percent chances of drop out. The participants will be taken from Mujahid hospital, Faisal Hospital and Madina teaching hospital. Participants will be assessed by using Oswestry Disability index and Numerical Pain Rating Scale NPRS for low back pain. Participants will be randomly allocated into two groups.One group will be treated with CFT and group based exercises and one with only group exercises. And at the end, data will be analyzed by using Statistical Package for the Social Sciences (SPSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: group based exercise with Cognitive functional therapygroup based exercises with Cognitive functional therapy |
| Group 2 | Active comparator | Other: Group based exercisegroup based exercise only |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pain level equal or more than 3 on NPRS A score of fourteen percent 14% or more on the Oswestry Disability Index (ODI) Low back pain for at least 6months duration
Key exclusion criteria (1 listed)
- Red flags (neoplastic diseases or cancer in the spine, inflammatory diseases, infections, and fractures) Neurological symptoms and psychiatric, rheumatologic, and cardiac diseases Radiculopathy with symptoms Lumbar stenosis Spondylolisthesis History of spinal surgeries Pregnancy
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 |
|---|---|---|
| group based exercise with Cognitive functional therapy1. Cognitive functional therapy CFT A cognitive functional therapy is the behavioral approach which is used to treat low back pain. This approach has 3 components Making sense of pain Exposure with control Lifestyle changes 2. Group exercises Group exercises will be the exercises that perform on all individuals. It is performed in a group session having 3 components Pain education Exercises Relaxation | Other | Group 1 |
| Group based exerciseGroup exercises Group exercises will be the exercises that perform on all individuals. It is performed in a group session having 3 components Pain education Exercises Relaxation | Other | Group 2 |
Primary outcome
NPRS
Time frame: Baseline
Numerical pain rating scale used to assess pain level
1 secondary outcome
ODI
Time frame: Baseline
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 6 Jan 2025.
- Background: PubMed 33744183Oiestad BE. Critically appraised paper: Cognitive functional therapy reduced disability compared with group-based exercise and education for chronic low back pain [synopsis]. J Physiother. 2021 Apr;67(2):141. doi: 10.1016/j.jphys.2021.01.004. Epub 2021 Mar 17. No abstract available.
- Background: PubMed 37548608Avila L, da Silva MD, Neves ML, Abreu AR, Fiuza CR, Fukusawa L, de Sa Ferreira A, Meziat-Filho N. Effectiveness of Cognitive Functional Therapy Versus Core Exercises and Manual Therapy in Patients With Chronic Low Back Pain After Spinal Surgery: Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad105. doi: 10.1093/ptj/pzad105.
- Background: PubMed 31630089O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.
- Individual participant dataSharing planned: No. Because every participants don't want to share and this will be written in the informed consent that their data will not shared
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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.
Questions about this trial
What is this clinical trial studying?
A study testing group based exercise with Cognitive functional therapy and Group based exercise in people with Low Back Pain, Chronic, run by University of Faisalabad.
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 1 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: opening soon, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Kashaf Zahra, Orthopedic Physiotherapy (+92 300 6688412, zahrakashaf931@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06759675, which also lists 3 linked publications.
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 6 Jan 2025.