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PainNCT02528812

Rolling Massage Decreases Pain Pressure Threshold

A study testing TheraBand Roller Massager and Manual Massage in people with Pain, run by Memorial University of Newfoundland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
TheraBand Roller Massager and Manual Massage
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
No sites listed yet
Study dates
Apr 2014to Oct 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Pain Pressure Threshold of a Muscle Tender Spot Increases Following Local and Non-local Rolling Massage

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.

Read the detailed description

In a randomized, single blinded, control trial study tender spots were identified in participants' plantar flexor muscles (gastrocnemius or soleus). The acute effect of different roller massage interventions on PPT (i.e. change in PPT from pre- to post-intervention) was investigated. Participants were not informed of the intervention groups. The same registered massage therapist who was blinded to the results of the pre- and post-intervention measurements administered the different modes of massage. In addition, the researcher who recorded the PPT values at pre- and post-intervention levels was blinded to the mode of intervention administered by the massage therapist. It has been shown that the intra-day and inter-day correlations for the algometry muscle tester ranges from 0.88 to 0.99 and 0.94 to 0.98, respectively. The CONSORT guidelines were followed throughout the current research study. The study duration was from June to October 2014.

Experimental protocol. Each participant attended the lab for one experimental session. The participants lay on a massage table in a prone position and a registered massage therapist with more than five years experience examined the relaxed plantar flexor muscles to identify tender spots. A tender spot was identified when an area was hyperirritable on palpation and pressure applied to the area with the pressure pain algometer (with approximately 4 kg/cm2) elicited localized pain greater than 5/10 on a visual analogue scale (VAS). The VAS scale was a horizontal line with anchors at the ends indicating no pain (score of 0) and intolerable pain (score of 10). The identified tender spots were marked with a permanent marker and the spot that exhibited the highest value was chosen for further measurements.

Then the local tenderness (dependent variable) was quantified (by the same massage therapist who screened the participants) measuring the PPT using the pressure pain algometer. The algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) was a hand-held muscle tester with a range of 0-300 pounds (136.1 kilograms) that consisted of a padded disc with a surface area of 1.7 cm2 attached to a microprocessor-control unit that measures peak force (pounds or kilograms). The unit has a digital readout for peak-applied pressure and provides a built-in calibration routine that verifies a valid calibration. In order to determine PPT, the researcher would apply the algometer to the tender spot on the participants calf muscle and increase the amount of pressure until the participant verbally informed the researcher when the sensation of pressure became pain at which point the algometer was removed and the PPT value was recorded. PPT values were obtained every 5-10 seconds over the tender spot using a pressure algometer and PPT was measured 6 times. Since the post-intervention PPT measurement was time sensitive, 6 PPT trials with 5-10 seconds interval were performed to gain a consistent value for this measurement.

After completion of pre-intervention PPT measurements, participants were randomly (using a random number generator) assigned to one of five intervention groups. The four massage intervention groups (Ipsi-R, Contra-R, Sham, Ipsi-M) involved 3 sets of 30 seconds massage with 30 seconds of rest between sets. The registered massage therapist performed the roller massage via a Theraband® roller massager (Hygienic Corporation, Akron, OH) technique on the Ipsi-R, Contra-R and Sham groups. The roller massager consisted of a hard rubber material (24 cm in length and 14 cm circumference) with low amplitude, longitudinal grooves surrounding a plastic cylinder. The participants were instructed to provide feedback on the level of perceived pain during the heavy rolling and manual massage (a combination of compressions and petrissage) and the intensity of massage would be adjusted accordingly to ensure 7/10 on the visual analogue scale (VAS) was maintained. 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. They lay on the table in prone position for three minutes until post-intervention data was collected. The Control group was assigned in the present study to account for the potential confounding influence of cutaneous touch in Sham.

Conditions
Pain
Being tested
TheraBand Roller Massager, Manual Massage
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TheraBand Roller MassagerDevice

    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.

  • Manual MassageOther

    A massage therapist massaged the participant

Study groups in NCT02528812
Study groupRoleWhat they receive
Ipsi-RExperimentalIntervention 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)
Receives: Device: TheraBand Roller Massager
Contra-RExperimentalIntervention group 2 included participants receiving heavy roller massage via the TheraBand Roller Massager on the calf of the contralateral limb (Contralateral Rolling: Contra-R)
Receives: Device: TheraBand Roller Massager
Sham groupSham comparatorThe sham group received light stroking of the skin with TheraBand roller massager on the calf that exhibited the higher tenderness
Receives: Device: TheraBand Roller Massager
Ipsi-MExperimentalIntervention group 3 included participants receiving manual massage on the calf that exhibited the higher tenderness (Ipsilateral Manual: Ipsi-M)
Receives: Other: Manual Massage
control groupNo interventionreceived no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain Pressure Threshold from pre- to post-interventions

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02528812
Sponsor's protocol ID
20140537-HK
Status last verified
Apr 2023
First submitted
14 Aug 2015
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26416265

Questions about this trial

What is this clinical trial studying?

A study testing TheraBand Roller Massager and Manual Massage in people with Pain, run by Memorial University of Newfoundland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Pressure Threshold from pre- to post-interventions (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02528812, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.

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