Chronic Low Back PainNCT03863808
Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization
A study testing Cognitive Behavioural Therapy and Strengthening exercises in people with Chronic Low Back Pain and Central Sensitisation, run by Marwa Elsayed at 1 site in Egypt.
Trial summary
PURPOSE: The main objectives of the study are: 1. To find the efficacy of using cognitive behavioural therapy on chronic low back pain with central sensitization. 2. To assist in planning an ideal physical therapy rehabilitation program for these patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Low Back Pain, Central Sensitisation
- What is being tested?
- Cognitive Behavioural Therapy and Strengthening exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2017to 18 Oct 2019
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18- 50.
- Patient must have experienced low back pain for at least 3 months.
- Patient must have a score above or equal 40 in the Central Sensitization Inventory (CSI) (Neblett R. C., 2013) (Neblett R, 2015) (Neblett H. M., 2016) (R. De Pauw, 2015) (Mayer TG N. R., 2012) .
- Patient must have a score of 3 and above on the Numerical Pain Rating Scale.
Who cannot join
- Patients were excluded if they had taken pain medications on the day of the assessment.
- Patient who had serious spinal pathologies, such as fractures, tumors or inflammatory diseases, such as ankylosing spondylitis, narrowing of spinal canal and other conditions or severe cardiorespiratory diseases.
- Uncontrolled mental health condition that prevents successful compliance.
Trial locations and contacts
1 site in 1 country.
About this study
PURPOSE:
The main objectives of the study are:
Read more
- To find the efficacy of using cognitive behavioural therapy on chronic low back pain with central sensitization.
- To assist in planning an ideal physical therapy rehabilitation program for these patients.
BACKGROUND:
Recent research has shown that CLBP is a multifactorial disorder comprising psychosocial factors like pain catastrophization, fear avoidance and central sensitization. Central sensitization has been defined as "An amplification of neural signaling within the central nervous system that elicits pain hypersensitivity", and "increased responsiveness of nociceptive neurons in the central nervous system to their normal or subthreshold afferent input".
Maladaptive behavior, false beliefs and misinformation regarding the cause of the pain are all contributing factors to the chronicity of LBP.
Central sensitization has been attributed to cortical reorganization and amplification of the somatosensory representation of the back causing increased pain and further contributing to the maladaptive behavior and beliefs.
Cognitive behavioral treatment has been an important intervention for psychological disorders for decades and recently has gained a lot of interest as an intervention for chronic pain in general and CLBP in specific.
HYPOTHESES:
It will be hypothesized that: Cognitive behavioural therapy will have a significant effect on centrally sensitized pain intensity and disability.
RESEARCH QUESTION:" Does cognitive behavioral therapy have a significant effect on chronic low back pain with central sensitization"
- Conditions
- Chronic Low Back Pain, Central Sensitisation
- Being tested
- Cognitive Behavioural Therapy, Strengthening exercises
- Keywords
- Cognitive Behavioural Therapy, Flexion Relaxation Phenomenon, Electromyography, Biofeedback, Functional Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
Also called SEMG Biofeedback
Following assessment a one on one session will be given comprising education cognitively targeting false ideas and beliefs on the nature of pain, differentiating nociception due to a painful stimulus and the transition of such a stimulus to a centrally sensitized experience due to misinformation, maladaptive behaviour and fear avoidance. Upon completion of the session assessment using the NPQ will be done to assess the understanding of the patient and further address any shortcomings in future exercise sessions.
Another SEMG recording of the Flexion Relaxation phenomenon will be upon completion of the educational session and a SEMG biofeedback session will begin to help the patient regain their sense of control over their body and function.
After the SEMG biofeedback session a graded exposure exercise program of strengthening and functional training starting from the least feared movements to the most over 10 sessions over 5 weeks.
Strengthening exercisesOther
Strengthening exercises in a gradual manner to the Multifidus and Transversus Abdominis muscles.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy | Experimental | Following assessment a one on one session will be given comprising education cognitively targeting false ideas and beliefs on the nature of pain, differentiating nociception due to a painful stimulus and the transition of such a stimulus to a centrally sensitized experience due to misinformation, maladaptive behaviour and fear avoidance. Upon completion of the session assessment using the NPQ will be done to assess the understanding of the patient and further address any shortcomings in future exercise sessions.
Another SEMG recording of the Flexion Relaxation phenomenon will be upon completion of the educational session and a SEMG biofeedback session will begin to help the patient regain their sense of control over their body and function.
After the SEMG biofeedback session a graded exposure exercise program of strengthening and functional training starting from the least feared movements to the most over 10 sessions over 5 weeks. Receives: Behavioral: Cognitive Behavioural Therapy |
| Strengthening and Core Stability | Active comparator | Following assessment 12 sessions over 6 weeks will start, focusing on strengthening exercises of the transversus abdominis and lumbar multifidus muscles (Angela Searle, 2015).
Exercises will be graduated according to the patient pain tolerance. Receives: Other: Strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Oswestry disability index
The Oswestry Disability Index (ODI) is one of the most commonly used outcome measures for individuals with low back pain (LBP) (Fairbank JC, 2000) .The ODI shows good construct validity; internal consistency is rated as acceptable; test-retest reliability and responsiveness have been shown to be high; and burden of administration is low. The ODI is a self-administered questionnaire that requires 5 minutes to complete and 1 minute to score.
Measured: Upto 24 weeks of treatment
Secondary outcomes (1)
The fear avoidance beliefs questionnaire
FABQ was developed by Waddell to investigate fear-avoidance beliefs among LBP patients in the clinical setting. This survey can help predict those that have a high pain avoidance behavior. The FABQ consists of 2 subscales, which are reflected in the division of the outcome form into 2 separate sections. The first subscale (items 1-5) is the Physical Activity subscale (FABQPA), and the second subscale (items 6-16) is the Work subscale (FABQW). Scoring the Physical Activity subscale (FABQPA) Sum items 2, 3, 4, and 5 (the score circled by the patient for these items). Scoring the Work subscale (FABQW) Sum items 6, 7, 9, 10, 11, 12, and 15.
Measured: Upto 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start2 Nov 2017
- Primary completion15 Aug 2019
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marwa Elsayed
- Sponsor type
- University, hospital or other
- Collaborators
- MTI University
- Responsible party
- Sponsor-investigator, Marwa Elsayed, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863808
- Sponsor's protocol ID
- 118992148
- Status last verified
- Mar 2023
- First submitted
- 23 Sep 2018
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only consented information will be shared.
Publications
. Airaksinen O, B. J.-M. (2006). European guidlines for the management of chronic nonspecific low back pain. Eur spine, 192-300. .: The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. . (2011). Arch Phys Med Rehabil, 2041-56. Ahern DK, F. M. (1988). Comparison of lumbar paravertebral EMG patterns in chronic low back pain patients and non-patient controls. Pain, 153-160. Airaksinen O, B. J.-M. (2006). European guidlines for the management of chronic nonspecific low back pain. Eur spine, 192-300. Angela Searle, M. S. (2015). Exercise interventions for the treatment of chronic low back pain: A systematic review and meta-analysis of randomised controlled trials. Clinical Rehabilitation, 1-13. Balagué F, M. A. (2012). Non specific low back pain. lance, 482-491. Clarke CL, R. C. (2011). Pain neurophysiology education for the management of individuals with chronic low back pain: systematic review and meta-analysis. Manual Therapy, 544-549. Cohen JE, G. V. (1994). Group education interventions for people with low back pain. An overview of the literature. Spine , 1214-22. Dagenais S, C. J. (2008). A systematic review of low back pain cost of illness studies in the United States and internationally. Spine, 8-20. DC, M. V. (2008). Psychometric properties and clinical usefulness of the Oswestry Disability Index. Journal of Chiropractice medicine, 161-163. Delitto. (2005). Research in low back pain: Time to stop seeking the elusive
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization
- ClinicalTrials.gov ID
- NCT03863808
- Acronym / sponsor ID
- 118992148
- Conditions
- Chronic Low Back Pain, Central Sensitisation
- Keywords
- Cognitive Behavioural Therapy, Flexion Relaxation Phenomenon, Electromyography, Biofeedback, Functional Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marwa ElsayedUniversity, hospital or other
- Collaborators
- MTI University
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 5 Mar 2019 (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.
PURPOSE:
The main objectives of the study are:
- To find the efficacy of using cognitive behavioural therapy on chronic low back pain with central sensitization.
- To assist in planning an ideal physical therapy rehabilitation program for these patients.
BACKGROUND:
Recent research has shown that CLBP is a multifactorial disorder comprising psychosocial factors like pain catastrophization, fear avoidance and central sensitization. Central sensitization has been defined as "An amplification of neural signaling within the central nervous system that elicits pain hypersensitivity", and "increased responsiveness of nociceptive neurons in the central nervous system to their normal or subthreshold afferent input".
Maladaptive behavior, false beliefs and misinformation regarding the cause of the pain are all contributing factors to the chronicity of LBP.
Central sensitization has been attributed to cortical reorganization and amplification of the somatosensory representation of the back causing increased pain and further contributing to the maladaptive behavior and beliefs.
Cognitive behavioral treatment has been an important intervention for psychological disorders for decades and recently has gained a lot of interest as an intervention for chronic pain in general and CLBP in specific.
HYPOTHESES:
It will be hypothesized that: Cognitive behavioural therapy will have a significant effect on centrally sensitized pain intensity and disability.
RESEARCH QUESTION:" Does cognitive behavioral therapy have a significant effect on chronic low back pain with central sensitization"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy | Experimental | Behavioral: Cognitive Behavioural TherapyFollowing assessment a one on one session will be given comprising education cognitively targeting false ideas and beliefs on the nature of pain, differentiating nociception due to a painful stimulus and the transition of such a stimulus to a centrally sensitized experience due to misinformation, maladaptive behaviour and fear avoidance. Upon completion of the session assessment using the NPQ will be done to assess the understanding of the patient and further address any shortcomings in future exercise sessions. Another SEMG recording of the Flexion Relaxation phenomenon will be upon completion of the educational session and a SEMG biofeedback session will begin to help the patient regain their sense of control over their body and function. After the SEMG biofeedback session a graded exposure exercise program of strengthening and functional training starting from the least feared movements to the most over 10 sessions over 5 weeks. |
| Strengthening and Core Stability | Active comparator | Other: Strengthening exercisesFollowing assessment 12 sessions over 6 weeks will start, focusing on strengthening exercises of the transversus abdominis and lumbar multifidus muscles (Angela Searle, 2015). Exercises will be graduated according to the patient pain tolerance. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18- 50.
- Patient must have experienced low back pain for at least 3 months.
- Patient must have a score above or equal 40 in the Central Sensitization Inventory (CSI) (Neblett R. C., 2013) (Neblett R, 2015) (Neblett H. M., 2016) (R. De Pauw, 2015) (Mayer TG N. R., 2012) .
- Patient must have a score of 3 and above on the Numerical Pain Rating Scale.
Key exclusion criteria (3 listed)
- Patients were excluded if they had taken pain medications on the day of the assessment.
- Patient who had serious spinal pathologies, such as fractures, tumors or inflammatory diseases, such as ankylosing spondylitis, narrowing of spinal canal and other conditions or severe cardiorespiratory diseases.
- Uncontrolled mental health condition that prevents successful compliance.
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 |
|---|---|---|
| Cognitive Behavioural TherapyAlso: SEMG BiofeedbackFollowing assessment a one on one session will be given comprising education cognitively targeting false ideas and beliefs on the nature of pain, differentiating nociception due to a painful stimulus and the transition of such a stimulus to a centrally sensitized experience due to misinformation, maladaptive behaviour and fear avoidance. Upon completion of the session assessment using the NPQ will be done to assess the understanding of the patient and further address any shortcomings in future exercise sessions. Another SEMG recording of the Flexion Relaxation phenomenon will be upon completion of the educational session and a SEMG biofeedback session will begin to help the patient regain their sense of control over their body and function. After the SEMG biofeedback session a graded exposure exercise program of strengthening and functional training starting from the least feared movements to the most over 10 sessions over 5 weeks. | Behavioural | Cognitive Behavioural Therapy |
| Strengthening exercisesStrengthening exercises in a gradual manner to the Multifidus and Transversus Abdominis muscles. | Other | Strengthening and Core Stability |
Primary outcome
The Oswestry disability index
Time frame: Upto 24 weeks of treatment
The Oswestry Disability Index (ODI) is one of the most commonly used outcome measures for individuals with low back pain (LBP) (Fairbank JC, 2000) .The ODI shows good construct validity; internal consistency is rated as acceptable; test-retest reliability and responsiveness have been shown to be high; and burden of administration is low. The ODI is a self-administered questionnaire that requires 5 minutes to complete and 1 minute to score.
1 secondary outcome
The fear avoidance beliefs questionnaire
Time frame: Upto 24 weeks of treatment
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 17 Mar 2023.
- Results publication. Airaksinen O, B. J.-M. (2006). European guidlines for the management of chronic nonspecific low back pain. Eur spine, 192-300. .: The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. . (2011). Arch Phys Med Rehabil, 2041-56. Ahern DK, F. M. (1988). Comparison of lumbar paravertebral EMG patterns in chronic low back pain patients and non-patient controls. Pain, 153-160. Airaksinen O, B. J.-M. (2006). European guidlines for the management of chronic nonspecific low back pain. Eur spine, 192-300. Angela Searle, M. S. (2015). Exercise interventions for the treatment of chronic low back pain: A systematic review and meta-analysis of randomised controlled trials. Clinical Rehabilitation, 1-13. Balagué F, M. A. (2012). Non specific low back pain. lance, 482-491. Clarke CL, R. C. (2011). Pain neurophysiology education for the management of individuals with chronic low back pain: systematic review and meta-analysis. Manual Therapy, 544-549. Cohen JE, G. V. (1994). Group education interventions for people with low back pain. An overview of the literature. Spine , 1214-22. Dagenais S, C. J. (2008). A systematic review of low back pain cost of illness studies in the United States and internationally. Spine, 8-20. DC, M. V. (2008). Psychometric properties and clinical usefulness of the Oswestry Disability Index. Journal of Chiropractice medicine, 161-163. Delitto. (2005). Research in low back pain: Time to stop seeking the elusive
- Individual participant dataSharing planned: Undecided. Only consented information will be 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. 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 Cognitive Behavioural Therapy and Strengthening exercises in people with Chronic Low Back Pain and Central Sensitisation, run by Marwa Elsayed 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 3 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 17 Mar 2023. 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?
The Oswestry disability index (time frame: Upto 24 weeks of treatment). 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 NCT03863808, which also lists 1 linked publication.
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 17 Mar 2023.