Foot Reflexology Therapy and Non-specific Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Effect of Foot Reflexology Therapy on Pain Intensity and Health-related Quality of Life in People With Non-specific Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02887430
• Other study ID #: UHREC/2016/2/011
• Status: Not yet recruiting
• Phase: Phase 0
• First received: August 19, 2016
• Last updated: September 6, 2016
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: September 2016
• Source: Universiti Sultan Zainal Abidin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to the standards care of low back pain according to the Malaysian low back pain management guidelines.

Description:

Low back pain is a common health complaint in most societies. Many treatments for low back pain aim to reduce suffering quicken recovery and minimize recurrence or development of chronic disability. However, low back pain continues as a societal enigma. The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to standards care of low back pain according to the Malaysian low back pain management guidelines. Analysis of health-related quality of life will also be carried out.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have been medically diagnosed with a non-specific low back pain.

• Have not received treatment for low back pain within the previous 2 weeks.

• Are at least 18 years old.

• Have both feet and all toes intact and free from wounds.

• Have not undergone any other complementary and alternative therapies during the study.

Exclusion Criteria:

• Have severe coexistent disease and serious pathology or systemic illness.

• Have a specific diagnosed cause of back pain (infection, tumour, osteoporosis, fracture, an inflammatory condition or cauda equine syndrome).

• Have plantar fasciitis.

• Lack the ability to read and write Malaysia language.

• Had plans to move out of the area.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• foot reflexology therapy
standard care and foot reflexology

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sultan Zainal Abidin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean time in days to the recovery of pain	the mean time in days to the recovery of pain is measured at the first day the patient scores 0 to 10 point on the visual analog scale (VAS)	5 months	No
Secondary	demographic information	demographic information including age, ethnicity, marital status, educational level, weight, height, household monthly income, smoking status, alcohol consumption, co-morbid disease and categories of low back pain.	3 month	No
Secondary	side effects of treatment	reporting of possible side effects of the treatment, both reflexology and medication	5 month	No
Secondary	health-related quality of life	measuring mean of health-related quality of life using Euro-quality of life 5D questionnaire before and after intervention	5 months	No