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COGNITIVE BEHAVIOURAL THERAPY FOR TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN

EFFECT OF COGNITIVE BEHAVIOURALTHERAPY IN TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04715789
Enrollment
40
Registered
2021-01-20
Start date
2020-10-20
Completion date
2021-09-30
Last updated
2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

graded eposure and activity

Brief summary

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.

Interventions

BEHAVIORALgraded exposure and activity

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 and progresses in a time contingent manner

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Masking description

The main investigator will perform the physical therapy program after referral by Blind assessor after assessment. Main investigator start the treatment based on the randomization made by the software after the referral so he will not know the assessment results before and after he treatment and the assessor will not know the randomization results and the patient group selected for treatment So this procedures will be done by double blind procedure for the main investigator and research assistance.

Intervention model description

Clinical trial controled study with double blind procedures for (main investigator) for treatment interventions and (research assistance) for assessment interventions.

Eligibility

Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patient's age between 25-40 years. 2. Patients have persistent Chronic Non-specific LBP for at least 3 months with or without leg pain. Leg pain won't exceeds mechanical behaviors. 3. Score of 24 fear avoidance questionnaire. 4. Symptoms of hypersensitivity, secondary punctate or pressure hyperalgesia and fear of movement as a central sensitization symptoms

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Arabic ODI for function5 minutesa)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

Secondary

MeasureTime frameDescription
Numerical rating scale5 minutespatient 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.
Tape measurement5 minutesthe 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
Fear avoidance belief questionnaire5 minutesThe 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

Countries

Egypt

Contacts

Primary Contactmohamed yehia, bachelor
yehiamohamed83@gmail.com+0201097726515
Backup Contactenas fawzy, doctoral
Enas.fawzy@pt.cu.edu.eg+0201127867507

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026