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

To explore the effect of adding cognitive-behavioral therapy to physical therapy interventions in patients with chronic non-specific back pain.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: graded exposure and activity

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Faculty of Physical Therapy Cairo University
    • Contact: enas fawzy; Phone Number: 01127867507; Email: Enas.fawzy@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: physical therapy intervention; core stability exercises:Multifidus exercisesFrontal & Side Plank exercisePelvic floor exercisesabdominal exercises; Strengthening exercisesBridgingstraight leg raisegluteus medius strengthgluteus maximus strengthening for about 20 min to 30 min to strength back and proximal hip control muscles	Behavioral: graded exposure and activity; 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
Experimental: graded exposure and graded activity in addition to phycal therapy intervention; 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 for about 10 min before physical therapy program (strengthening)	Behavioral: graded exposure and activity; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	5 minutes

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

Helpful Links

• https://pubmed.ncbi.nlm.nih.gov/

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 16, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: graded eposure and activity
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: COGNITIVE BEHAVIOURAL THERAPY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No