Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02528812 |
| Other study ID # |
20140537-HK |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2014 |
| Est. completion date |
October 2014 |
Study information
| Verified date |
April 2023 |
| Source |
Memorial University of Newfoundland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 (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.
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.
