NCT06095336

Brief Summary

The study was planned to investigate the effectiveness of home therapy method due to the difficulties experienced by caregivers of individuals with special needs in accessing physiotherapy and rehabilitation services for chronic neck and back pain.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

September 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

October 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

September 20, 2023

Last Update Submit

October 18, 2023

Conditions

TelerehabilitationNeck Pain

Keywords

individual with special needsback pain

Outcome Measures

Primary Outcomes (5)

  • Demographic information form

    The survey form prepared by the researcher in line with the literature includes information about the patients' name, surname, CV, family history, age, height, weight, occupation, dominant side, smoking and alcohol use, and additional symptoms.

    before treatment

  • Qualitative Questions Form

    A form containing questions asking about the number of individuals with special needs that they care for, the time they spend with the individual with special needs on a daily basis, the presence of another child other than the individual with special needs that they care for, whether there is help at home, the GMFCS Score of the individuals being cared for, and whether physical, mental or both effects are at the same time. will be prepared and implemented.

    before treatment, after treatment, after 6 months

  • Pain Assessment

    Visual Analog Scale (VAS) was used to determine the severity of pain in the cases. The beginning will be marked as 0 (no pain) and the end (unbearable pain) on a 10 centimeter (cm) horizontal line, and the subjects will be asked to make a mark on this horizontal line according to the degree of pain they feel. The marked point on the line will then be measured with the help of a ruler and recorded as the VAS value in cm.

    before treatment, after treatment, after 6 months

  • Fatigue Assessment:

    The FACIT Scale is a measurement tool consisting of 13 statements that subjectively evaluates fatigue in the last week. The scale has a five-point Likert scale: "0 = not at all, 1 = very little, 2 = a little, 3 = quite a bit and 4 = very much." 11 items (1-6, 9-13) of the scale contain reverse expressions. Items 7 and 8 of the scale are calculated as straight. The scores that can be obtained from the scale vary between 0-52. A high total score of the scale indicates that the severity of fatigue is low. If the score obtained from the scale is 30 or less, it is reported that perceived fatigue is clinically severe.

    before treatment, after treatment, after 6 months

  • Short Form-36 (Short Form-36, SF-36):

    It is a valid and frequently used measure to evaluate quality of life. It includes 36 questions in eight subscales: physical function, physical role limitation, emotional role limitation, body pain, social function, mental health, vitality, and general health.

    before treatment, after treatment, after 6 months

Secondary Outcomes (2)

  • Bournemouth Neck Pain Survey:

    before treatment, after treatment, after 6 months

  • Caregiving Burden Scale:

    before treatment, after treatment, after 6 months

Study Arms (3)

Telereahabilitation arm

EXPERIMENTAL

The group receiving telerehabilitation will be given a video CD containing the exercise program that will be changed every 3 weeks, and in the first week of each change program, daily sessions will be held collectively via video conferencing under the supervision of a physiotherapist. In the first 3 weeks of the 12-week exercise program, neck joint movements, neck stretching exercises and posture exercises will be given. Between weeks 4-6, in addition to the exercises in the first 3 weeks, cervical and scapular stabilization exercises will be given in the following weeks. In the following weeks, between weeks 7-9, 4-way strengthening exercises will be included in the program in addition to the exercises performed in the previous weeks. Cervical and scapular stabilization exercises and strengthening exercises will be performed in the following weeks between weeks 10-12, Exercises will be done 10 repetitions 3 times a day.

Other: telerehabilitation

conventional physiotherapy arm

EXPERIMENTAL

Superficial heat (infrared), "Transcutaneous Electrical Nerve Stimulation" (TENS), therapeutic ultrasound and Hotpack application will be applied to the traditional treatment group. The patients receive 20 sessions in total, 5 days a week and 1 session daily for 4 weeks; You will receive superficial heat (infrared), TENS, therapeutic US and Hotpack treatment. . Superficial heat infrared will be applied to the tissue for 20 minutes. Conventional TENS will be applied. Therapeutic US will be applied to the cervical and thoracic region with an ultrasound device for 5 minutes at 3mHz, 1W/cm² treatment dosage, in continuous mode. Hotpack application will be done for 20 minutes. At the end of the 20 sessions, a brochure containing video-supported exercises will be given to the patients in the first group and they will be asked to do it for 12 weeks without follow-up.

Other: telerehabilitation

control arm

NO INTERVENTION

The third group, the control group, will not receive any intervention and will be asked to continue their daily lives.

Interventions

telerehabilitationOTHER

The individuals included in the research will be divided into three groups. Group 1 (experiment): This is the exercise group followed by the telerehabilitation method. Group 2 (experiment): This is the group where traditional physical therapy methods will be applied. The 3rd group will be taken as the control group, there will be no intervention and they will be asked to continue their daily lives.

Also known as: conventional physiotherapy, control
Telereahabilitation armconventional physiotherapy arm

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 20-60 years old,
  • Being a special needs child caregiver,
  • Mechanical neck and back pain lasting 3 months or longer

You may not qualify if:

  • Those who are caregivers of hearing and visually impaired children,
  • Having previously undergone surgery in the cervical region,
  • Patients with a history of inflammatory or infective arthritis in the cervical spine,
  • Congenital spinal cord anomaly,
  • history of malignancy,
  • Having neuropathic pain
  • Radiculopathy, myelopathy or other neurological disorders
  • Those with chronic lung disease
  • Vestibular disorders,
  • Those with a history of continuous drug use,
  • Individuals who have been involved in an exercise or physiotherapy program in the last 3 months,
  • He will not be able to read the scales and the evaluation parameters will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Terzi R, Tan G. Musculoskeletal system pain and related factors in mothers of children with cerebral palsy. Agri. 2016 Jan;28(1):18-24. doi: 10.5505/agri.2015.74436.

    PMID: 27225608BACKGROUND

  • Hailey D, Roine R, Ohinmaa A, Dennett L. Evidence of benefit from telerehabilitation in routine care: a systematic review. J Telemed Telecare. 2011;17(6):281-7. doi: 10.1258/jtt.2011.101208. Epub 2011 Aug 15.

    PMID: 21844172BACKGROUND

Related Links

MeSH Terms

Conditions

Neck PainBack Pain

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • burak buğday

    Inonu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

burak buğday

CONTACT

5357306877burak.bugday@inonu.edu.tr

havva adlı

CONTACT

5369831133havva.adli@inonu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants in the study did not know the group they belonged to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In the study, which was planned as a randomized controlled study, participants were randomly divided into 3 groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 20, 2023

First Posted

October 23, 2023

Study Start

October 28, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share