The Effectiveness of Telerehabilitation Modalities in Physical Therapy in the Management of Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Effectiveness of Telerehabilitation Modalities in Physical Therapy in the Management of Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756740
• Other study ID #: 196/18
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2021
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low back pain (LBP), a common disorder, causes disability, functional decline and high health care costs. Patient care programs include specific exercises for promoting function and improving health. Self-practice and adherence to treatment are important for treatment success and better outcomes. Telerehabilitation (TR) might improve patient symptoms, compliance to treatment and reduce patient symptoms, however, its effectiveness in treating LBP, still needs further investigation.

The overall aim of this study will be to examine the effectiveness of combining telerehabilitation within physical therapy treatments for patients with LBP

Description:

The study will include 60 patients complaining of chronic nonspecific LBP over a 6 month period of time and referred for physical therapy treatment. They will undergo a routine physical examination and be assigned a personal treatment (manual therapy and electrotherapy) and exercise program in accordance with their condition. Participants will receive a total of 8 treatments over a 4-week period (twice a week).

The sample will be randomly divided into 2 groups: a. research group A will receive a video of the exercises via e-mails or to their cellphones; b. a control group will receive the exercises printed on paper.

The exercises will be recorded and be supplemented by a verbal explanation and instructions as to how to correctly perform the exercises. In total, there will be ten videos, found to be important and effective for LBP patients. From these videos, a physical therapist will choose the most suitable exercises for the patients after each treatment meeting (face to face). The patients will be assessed at baseline, at the end of treatment and at a 3 month follow-up telephone assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Main complaint of nonspecific LBP over a 3 month period

• Possess a smartphone, e-mail and the understanding of using these tools for viewing videos.

Exclusion Criteria:

• Signs or symptoms of possible malignancy are present, such as unexplained weight loss, slight or no reduction of pain while in a recumbent position or subjects were not screened prior to referral to physical therapy.

• two or more of the following signs are present on physical examination: lower extremity weakness in a myotome distribution, decreased sensation in a dermatomal distribution, altered lower extremity deep tendon reflexes, pathological reflexes, a positive straight leg raise (SLR) test, crossed SLR or femoral nerve stretch test.

• Symptoms began immediately after a significant trauma (motor vehicle accident, fall from a height) and subjects were not been screened for possible fractures.

• Physical therapy or chiropractic treatment for LBP was provided during the 6 months prior to participation in the study or are currently being treated.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• telerehabilitation and physical therapy
subject will receive the LBP exercises as a video to his/her mobile or e-mail
• control
subjects will receive the LBP exercises as printed pictures on paper

Locations

Country	Name	City	State
Israel	University of Haifa	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Maccabi Healthcare Services, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale	level of pain on an 11-point numeric pain rating scale	3 months
Primary	Modified Oswestry Disability Index	questionnaire to assess the disability level associated with LBP and includes 10 questions regarding activities likely to be affected by LBP	3 months
Primary	Fear-Avoidance Beliefs Questionnaire	questionnaire to assess the subject's beliefs as to the potential harm of several physical and work-related activities	3 months
Primary	Survey Health Form Short	questionnaire to assess the subject's belief as to his/her health-related quality of life	3 months
Secondary	Global rating of change	a 15-point Likert scale ranging to assess treatment success	3 months
Secondary	A questionnaire regarding treatment satisfaction	a 5-point Likert scale to assess patient satisfaction from treatment	3 months