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

NCT04715789 | Unknown

• 1 other identifier: COGNITIVE BEHAVIOURAL THERAPY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Keywords

graded eposure and activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Numerical rating scale

  5 minutes

• Tape measurement

  5 minutes

• Fear avoidance belief questionnaire

  5 minutes

Study Arms (2)

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

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)

Behavioral: graded exposure and activity

Interventions

graded exposure and activity BEHAVIORAL

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

graded exposure and graded activity in addition to phycal therapy intervention; physical therapy intervention

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Egypt

RECRUITING

Related Links

• https://pubmed.ncbi.nlm.nih.gov/

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

mohamed yehia, bachelor

CONTACT

+0201097726515; yehiamohamed83@gmail.com

enas fawzy, doctoral

CONTACT

+0201127867507; Enas.fawzy@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phyisical therapist at qena oncology center

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

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 20, 2021
• Study Start: October 20, 2020
• Primary Completion: April 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

EG (1)