ENBORTH-TR Intervention for Back/Neck Pain

NCT06916533 | Completed

• 1 other identifier: 2024/209
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to investigate the effectiveness of the ENBORTH-TR training programme given in addition to client-centred intervention in individuals with low back and/or neck pain. The current study investigates the effect of ENBORTH-TR on pain, quality of life, sleep quality, kinesiophobia and perceived occupational performance and satisfaction levels. This study was designed according to the CONSORT statement, which provides standardisation in randomised controlled trials. In addition, the study was approved by the scientific research ethics committee of a university. Written informed consent was obtained from all participants before the study.

Conditions

Low Back Pain; Neck Pain

Keywords

low back pain; neck pain; quality of life; sleep quality; occupational performance; satisfaction; kinesiophobia

Outcome Measures

Primary Outcomes (4)

• Canadian Occupational Performance Measure (COPM)

  COPM, which is most frequently used among occupational therapists, is a standardised measurement tool used to determine the individual's activity performance problems and to measure performance satisfaction. In the COPM, which is a semi-structured interview, individuals evaluate their activity preferences with performance and satisfaction scores given by themselves. Individuals are asked about their activity performance problems and concerns about 3 areas including self-care, productivity and leisure time activities. Up to three problems can be identified in each activity area (self-care, productivity, leisure). Performance and satisfaction scores are again determined by the individual between 1 and 10 points.

  30 minutes

• Visual Analog Scale (VAS)

  Visual analogue scale was used to assess the pain intensity of the participants. During the assessment, the participants were asked to mark the points where they felt pain during sleep, rest and activity on a 10 cm horizontal line with the left end 0 meaning 'no pain' and the right end 10 meaning 'very severe pain'. Before marking, the individuals were explained in detail what they should do. Then, the distance of the marked points to point 0 was measured and recorded in centimetres

  5 minutes

• Tampa Scale of Kinesiophobia (TSK)

  The TSK, which is used in the evaluation of kinesiophobia, is a Likert-type scale consisting of 17 questions. Each question is scored between 1 and 4 points (1 = strongly disagree to 4 = strongly agree). The lowest score that can be obtained from the scale is 17 and the highest score is 68. A high score in the total score of the scale indicates a high level of kinesiophobia.

  7 minutes

• Nottingham Health Profile (NHP)

  The NHP used to assess the people's QoL consists of a total of 38 questions. It has 6 subscales and assesses energy, pain, emotional reactions, sleep, social isolation and physical activity. Scoring is done between 0 and 100, with a high score indicating a low QoL.

  10 minutes

Secondary Outcomes (1)

• The Pittsburgh Sleep Quality Index (PSQI)

  15 minutes

Study Arms (2)

Control Group

EXPERIMENTAL

According to the evaluation results, client-centred occupational therapy intervention was applied to this group. The client-centred occupational therapy intervention is based on the activities that the participants stated in the COPM in the first evaluation and had problems.

Behavioral: Client-centred Occupational Therapy Intervention Group

ENBORTH-TR Invertention Group

EXPERIMENTAL

In this study, ENBORTH-TR training programme is applied in addition to person-centred intervention. ENBORTH-TR programme starts from the definition of pain, explains its mechanism, affected muscle groups, and provides awareness training that will improve the quality of life of individuals in pain management such as environmental regulations, relaxation techniques, stress management.

Behavioral: ENBORTH-TR Intervention; Behavioral: Client-centred Occupational Therapy Intervention Group

Interventions

ENBORTH-TR Intervention BEHAVIORAL

This intervention program is structured with a multifaceted and holistic approach, starting with the definition of pain and covering topics such as basic body anatomy, functions and pain mechanisms, ergonomics training, environmental regulations, psychosocial factors such as stress, relaxation techniques, sleep and time management.

ENBORTH-TR Invertention Group

Client-centred Occupational Therapy Intervention Group BEHAVIORAL

Client-centered occupational therapy intervention consists of 5 stages: (1) Client-centered goal setting, (2) creation of the therapy plan, (3) implementation of interventions, (4) evaluation of results, and (5) obtaining feedback.

Control Group; ENBORTH-TR Invertention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be at least primary school graduate
• Participating in the study voluntarily
• To be able to read and write Turkish
• At least 24 points from the Mini Mental State Examination
• Having low back and neck pain for 3 months or more
• Being between the ages of 18-65

You may not qualify if:

• Having a neurological, psychiatric or chronic disease (cancer, etc.) or having any secondary disease that will adversely affect the work
• History of any malignancy or spinal fracture
• Having undergone a surgical procedure for low back and/or neck pain or having undergone any other surgical intervention within the last 6 months
• Not participating regularly in the intervention process
• Participating in another rehabilitation program during the study period
• \) Diagnosis of pregnancy or suspected pregnancy

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Science

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Neck Pain; Sleep Initiation and Maintenance Disorders; Personal Satisfaction; Kinesiophobia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior; Phobic Disorders; Anxiety Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: October 10, 2024
• Primary Completion: February 28, 2025
• Study Completion: April 5, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)