NCT02887430

Brief 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.

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
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2016

Shorter than P25 for early_phase_1

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

1 month

First QC Date

August 19, 2016

Last Update Submit

September 6, 2016

Conditions

Low Back Pain

Keywords

foot reflexologypain intensityhealth-related quality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • demographic information

    3 month

  • side effects of treatment

    5 month

  • health-related quality of life

    5 months

Study Arms (2)

intervention

EXPERIMENTAL

Participants will be received 8 sessions of foot reflexology therapy, 30 minutes each (2 sessions per week of 4 weeks) and low back pain standard care

Other: foot reflexology therapy

control

NO INTERVENTION

participants will be received standard care in general practice

Interventions

foot reflexology therapyOTHER

standard care and foot reflexology

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 19, 2016

First Posted

September 2, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2016

Study Completion

February 1, 2017

Last Updated

September 8, 2016

Record last verified: 2016-09