Low Back PainNCT04715789
COGNITIVE BEHAVIOURAL THERAPY FOR TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN
A study testing graded exposure and activity in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
To explore the effect of adding cognitive-behavioral therapy to physical therapy interventions in patients with chronic non-specific back pain. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- graded exposure and activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2020to Sep 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient's age between 25-40 years.
- Patients have persistent Chronic Non-specific LBP for at least 3 months with or without leg pain. Leg pain won't exceeds mechanical behaviors.
- Score of 24 fear avoidance questionnaire.
- Symptoms of hypersensitivity, secondary punctate or pressure hyperalgesia and fear of movement as a central sensitization symptoms
Who cannot join
- 1-History of previous back surgery. 2- History of previous hip, knee or ankle surgeries. 3- Systemic inflammatory diseases. 4-Tumors. 5-Red flags of back pain 6-Patients with disc pathology and radicular pain 7- spinal fracture or spinal surgery 8- systemic disease or TB of spine widespread constant non-specific pain disorder, pain without a clear mechanical behavior
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Giza
enas fawzy, 01127867507, Enas.fawzy@pt.cu.edu.eg
About this study
Official title: EFFECT OF COGNITIVE BEHAVIOURALTHERAPY IN TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN
To explore the effect of adding cognitive-behavioral therapy to physical therapy interventions in patients with chronic non-specific back pain.
Read the detailed description
Studies suggest that patients with LBP benefited when standard rehabilitation approaches were supplemented with graded exercise . There is adequate information to allow clinical implementation of graded exercise by physical therapists, In contrast, there is less information available for physical therapy implementation of graded exposure. LBP rehabilitation based on graded exposure principles Therefore, the purpose of this study is to review the available evidence for graded exposure and to describe physical therapy application of graded exposure for patients enrolled in clinical trial.
- Conditions
- Low Back Pain
- Being tested
- graded exposure and activity
- Keywords
- graded eposure and activity
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
graded exposure and activityBehavioural
- Graded exposure: This approach followed a model where the patient was gradually exposed to previously pain provocative, feared and or avoided tasks. These activities are started at a diminished level that elicits minimal amounts of fear and then gradually increased to situations that elicit larger amounts of fear patients are asked to create a hierarchy of feared activities. The exposure starts with the least feared activity, and the therapist helps the patient appraise the exposure and its consequences and then address irrational and counterproductive beliefs, leading to reductions in the anxiety associated with the activity
- Graded activity exercises: The new postural and movement behaviors were integrated into each person's nominated pain provocative functional activities linked to their goals in order to generalize learning and build self-efficacy the program focuses on functional activities and progresses in a time contingent manner
| Study group | Role | What they receive |
|---|---|---|
| physical therapy intervention | Experimental | 1. core stability exercises:
1. Multifidus exercises
2. Frontal \& Side Plank exercise
3. Pelvic floor exercises
4. abdominal exercises
2. Strengthening exercises
1. Bridging
2. straight leg raise
3. gluteus medius strength
4. gluteus maximus strengthening for about 20 min to 30 min to strength back and proximal hip control muscles Receives: Behavioral: graded exposure and activity |
| graded exposure and graded activity in addition to phycal therapy intervention | Experimental | 1. Graded exposure:This approach followed a model where the patient was gradually exposed to previously pain provocative, feared and or avoided tasks. These activities are started at a diminished level that elicits minimal amounts of fear and then gradually increased to situations that elicit larger amounts of fear patients are asked to create a hierarchy of feared activities. The exposure starts with the least feared activity, and the therapist helps the patient appraise the exposure and its consequences and then address irrational and counterproductive beliefs, leading to reductions in the anxiety associated with the activity
2. Graded activity exercises: The new postural and movement behaviors were integrated into each person's nominated pain provocative functional activities linked to their goals in order to generalize learning and build self-efficacy the program focuses on functional activities for about 10 min before physical therapy program (strengthening) Receives: Behavioral: graded exposure and activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arabic ODI for function
a)ODI ASSESMENT: Patient-completed questionnaire which gives a percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. In pre session and after end of sessions This Questionnaire examines perceived level of disability in 10 everyday activities of daily living.
The 6 statements are scored from 0 to 5 with the first statement scoring 0 through to the last at5 If all 10 sections are completed the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32% Scores: 1- (0% to 20%): minimal disability 2-(21%-40%: moderate disability) 3- (41%-60%): severe disability 4-(61%-80%: crippled) 5-(81%-100%) These patients are either bed-bound or exaggerating their symptoms
Measured: 5 minutes
Secondary outcomes (3)
Numerical rating scale
patient will sign the degree of pain from(0to 10) the assessment will be done in pretreatment and post treatment as an outcome measure for pain intensity.
Measured: 5 minutes
Tape measurement
the patient will be informed about the rules of upright position and asked to position himself in front of the mirror. This posture was recorded as the upright position of the patient and the measurements for the posture analysis were recorded by means of a tape measure from c7 to s2
Measured: 5 minutes
Fear avoidance belief questionnaire
The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. the patient fill the questionnaire in first session and at last session
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start20 Oct 2020
- Primary completionApr 2021 (estimated)
- Study completionSep 2021 (estimated)
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
- Clinical trial controled study with double blind procedures for (main investigator) for treatment interventions and (research assistance) for assessment interventions.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohmed yehia elabd hasan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715789
- Sponsor's protocol ID
- COGNITIVE BEHAVIOURAL THERAPY
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF COGNITIVE BEHAVIOURALTHERAPY IN TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN
- ClinicalTrials.gov ID
- NCT04715789
- Acronym / sponsor ID
- COGNITIVE BEHAVIOURAL THERAPY
- Conditions
- Low Back Pain
- Keywords
- graded eposure and activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 20 Jan 2021 (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.
To explore the effect of adding cognitive-behavioral therapy to physical therapy interventions in patients with chronic non-specific back pain.
Detailed description
Studies suggest that patients with LBP benefited when standard rehabilitation approaches were supplemented with graded exercise . There is adequate information to allow clinical implementation of graded exercise by physical therapists, In contrast, there is less information available for physical therapy implementation of graded exposure. LBP rehabilitation based on graded exposure principles Therefore, the purpose of this study is to review the available evidence for graded exposure and to describe physical therapy application of graded exposure for patients enrolled in clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Clinical trial controled study with double blind procedures for (main investigator) for treatment interventions and (research assistance) for assessment interventions.
| Arm | Type | Receives |
|---|---|---|
| physical therapy intervention | Experimental | Behavioral: graded exposure and activity1. core stability exercises: 1. Multifidus exercises 2. Frontal \& Side Plank exercise 3. Pelvic floor exercises 4. abdominal exercises 2. Strengthening exercises 1. Bridging 2. straight leg raise 3. gluteus medius strength 4. gluteus maximus strengthening for about 20 min to 30 min to strength back and proximal hip control muscles |
| graded exposure and graded activity in addition to phycal therapy intervention | Experimental | Behavioral: graded exposure and activity1. Graded exposure:This approach followed a model where the patient was gradually exposed to previously pain provocative, feared and or avoided tasks. These activities are started at a diminished level that elicits minimal amounts of fear and then gradually increased to situations that elicit larger amounts of fear patients are asked to create a hierarchy of feared activities. The exposure starts with the least feared activity, and the therapist helps the patient appraise the exposure and its consequences and then address irrational and counterproductive beliefs, leading to reductions in the anxiety associated with the activity 2. Graded activity exercises: The new postural and movement behaviors were integrated into each person's nominated pain provocative functional activities linked to their goals in order to generalize learning and build self-efficacy the program focuses on functional activities for about 10 min before physical therapy program (strengthening) |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient's age between 25-40 years.
- Patients have persistent Chronic Non-specific LBP for at least 3 months with or without leg pain. Leg pain won't exceeds mechanical behaviors.
- Score of 24 fear avoidance questionnaire.
- Symptoms of hypersensitivity, secondary punctate or pressure hyperalgesia and fear of movement as a central sensitization symptoms
Key exclusion criteria (1 listed)
- 1-History of previous back surgery. 2- History of previous hip, knee or ankle surgeries. 3- Systemic inflammatory diseases. 4-Tumors. 5-Red flags of back pain 6-Patients with disc pathology and radicular pain 7- spinal fracture or spinal surgery 8- systemic disease or TB of spine widespread constant non-specific pain disorder, pain without a clear mechanical behavior
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 |
|---|---|---|
| graded exposure and activity1. Graded exposure: This approach followed a model where the patient was gradually exposed to previously pain provocative, feared and or avoided tasks. These activities are started at a diminished level that elicits minimal amounts of fear and then gradually increased to situations that elicit larger amounts of fear patients are asked to create a hierarchy of feared activities. The exposure starts with the least feared activity, and the therapist helps the patient appraise the exposure and its consequences and then address irrational and counterproductive beliefs, leading to reductions in the anxiety associated with the activity 2. Graded activity exercises: The new postural and movement behaviors were integrated into each person's nominated pain provocative functional activities linked to their goals in order to generalize learning and build self-efficacy the program focuses on functional activities and progresses in a time contingent manner | Behavioural | graded exposure and graded activity in addition to phycal therapy intervention, physical therapy intervention |
Primary outcome
Arabic ODI for function
Time frame: 5 minutes
a)ODI ASSESMENT: Patient-completed questionnaire which gives a percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. In pre session and after end of sessions This Questionnaire examines perceived level of disability in 10 everyday activities of daily living. The 6 statements are scored from 0 to 5 with the first statement scoring 0 through to the last at5 If all 10 sections are completed the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32% Scores: 1- (0% to 20%): minimal disability 2-(21%-40%: moderate disability) 3- (41%-60%): severe disability 4-(61%-80%: crippled) 5-(81%-100%) These patients are either bed-bound or exaggerating their symptoms
3 secondary outcomes
Numerical rating scale
Time frame: 5 minutes
Tape measurement
Time frame: 5 minutes
Fear avoidance belief questionnaire
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- https://pubmed.ncbi.nlm.nih.gov/Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing graded exposure and activity 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 4 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed yehia, bachelor (+0201097726515, yehiamohamed83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arabic ODI for function (time frame: 5 minutes). 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 20 Jan 2021.