NCT02528812

Brief Summary

In a randomized control trial and single blinded study, tender spots were identified in 150 participants' plantar flexor muscles (gastrocnemius or soleus). Then participants were randomly assigned to one of five intervention groups (n = 30): 1) heavy rolling massage on the calf that exhibited the higher tenderness (Ipsi-R), 2) heavy rolling massage on the contralateral calf (Contra-R), 3) light stroking of the skin with roller massager on the calf that exhibited the higher tenderness (Sham), 4) manual massage on the calf that exhibited the higher tenderness (Ipsi-M) and 5) no intervention (Control). Pain pressure threshold (PPT) was measured at 30 seconds and up to 15 minutes post-intervention via a pressure algometer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable pain

Status
completed

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

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

August 14, 2015

Last Update Submit

April 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Pressure Threshold from pre- to post-interventions

    PPT values were obtained over the tender spot and PPT was measured 6 times. PPT measurements were repeated at 2, 5, 10, and 15 minutes following interventions.

Study Arms (5)

Ipsi-R

EXPERIMENTAL

Intervention group 1 included participants receiving heavy roller massage via the TheraBand Roller Massager on the calf that exhibited the higher tenderness (Ipsilateral Rolling: Ipsi-R)

Device: TheraBand Roller Massager

Contra-R

EXPERIMENTAL

Intervention group 2 included participants receiving heavy roller massage via the TheraBand Roller Massager on the calf of the contralateral limb (Contralateral Rolling: Contra-R)

Device: TheraBand Roller Massager

Sham group

SHAM COMPARATOR

The sham group received light stroking of the skin with TheraBand roller massager on the calf that exhibited the higher tenderness

Device: TheraBand Roller Massager

Ipsi-M

EXPERIMENTAL

Intervention group 3 included participants receiving manual massage on the calf that exhibited the higher tenderness (Ipsilateral Manual: Ipsi-M)

Other: Manual Massage

control group

NO INTERVENTION

received no intervention

Interventions

The roller massager was moved proximal to distal at a slow pace (2 seconds up and 2 second downs) over the muscle belly. Participants in the Sham group received very light pain-free cutaneous strokes of rolling massage with the same pace of rolling as performed for the Ipsi-R and Contra-R groups. The Control group did not receive any treatment.

Contra-RIpsi-RSham group

A massage therapist massaged the participant

Ipsi-M

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • participants had to exhibit point tenderness in their plantar flexor muscles (gastrocnemius or soleus) either in the left or right limb.

You may not qualify if:

  • having musculoskeletal or visceral chronic pain and taking pain relief medications within the past 24 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Aboodarda SJ, Spence AJ, Button DC. Pain pressure threshold of a muscle tender spot increases following local and non-local rolling massage. BMC Musculoskelet Disord. 2015 Sep 28;16:265. doi: 10.1186/s12891-015-0729-5.

MeSH Terms

Conditions

Pain

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Officials

  • Duane Button, PhD

    Memorial University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 19, 2015

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 13, 2023

Record last verified: 2023-04