NCT04938739

Brief Summary

The purpose of the study is to determine the effectiveness of cognitive-behavioral therapy on functional outcomes, pain, and pain-related anxiety in patients with chronic nonspecific low back pain

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 16, 2021

Last Update Submit

June 16, 2021

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (2)

  • Assessing the change in pain intensity

    Assessment via using visual analogue scale A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one

    Baseline and 6 weeks post-intervention

  • Assessing the change in back function

    Assessment via using Oswestry Low Back Pain Disability Index It is a 10-item self assessing questionnaire; each item contains 6 levels of answers that can be scored from 0 to 5.

    Baseline and 6 weeks post-intervention

Secondary Outcomes (1)

  • Assessing the change in anxiety related to pain

    Baseline and 6 weeks post-intervention

Study Arms (2)

Cognitive Behavioral therapy

EXPERIMENTAL

to modify any erroneous beliefs about pain and disability and to promote coping strategies and self-efficacy through a graded activity.

Other: Cognitive Behavioral TherapyOther: Home program exercises

Home program exercises

ACTIVE COMPARATOR

Patients in both groups carried out exercise therapy for six weeks. There will be an educational session for each patient to make sure the exercises will be done successfully and supervision once per week.

Other: Home program exercises

Interventions

Cognitive Behavioral TherapyOTHER

The first 6 sessions: the cognitive part was explained with the support of a PowerPoint presentation using diagrams, images, and texts. The therapist explained the lumbar engine behavior, the neurophysiologic basis of pain, the importance of the participant's involvement in the treatment (e.g., coping and motivation), and the maintenance of good ergonomics which was aimed at modifying the physiologic response to the pain system. The second 12 sessions: concepts viewed in the first session were revised; as well, the operant and respondent parts were explained.

Cognitive Behavioral therapy
Home program exercisesOTHER

Each session will include 10 minutes of aerobic activity (walking or stationary bicycle), followed by five types of muscle stretches and eight types of ground exercises aimed at strengthening the lumbar muscles responsible for stabilization.

Cognitive Behavioral therapyHome program exercises

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Thirty patients with non-specific chronic low back pain from both sexes will be included.
  • Subjects with normal body mass index (18 to 25).
  • The age of patients range from 20 to 35 years.
  • Duration of pain more than 3 months up to 2 years.
  • Normal cognition score 26 or above according to MoCA Scale.7. Highly educated at least high school.

You may not qualify if:

  • The patients will be excluded if they have any of the followings:
  • Lumbar canal stenosis.
  • Lumbar discogenic lesions.
  • Any inflammatory arthritis, tumors, infection involving the lumbar spine.
  • Patients with decreased range of motion secondary to congenital anomalies, muscular contracture or bony block.
  • Previous lumbar surgery or trauma.
  • Subjects with a history of any neurologic disease.
  • Cauda equina Syndrome.
  • Patients suffering from psychological, cognitive or emotional disturbance.
  • Patients who had previously participated in cognitive behavioral therapy.
  • Deafness and blindness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic - Faculty of Physical Therapy - Cairo University

Dokki, 34518, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Manar Abdelgalil, Abdelgalil

    Horus University in Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 24, 2021

Study Start

December 1, 2020

Primary Completion

January 15, 2021

Study Completion

February 28, 2021

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)