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.
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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 Receives: 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) Receives: Other: Manual Massage |
| control group | No intervention | received no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted19 Aug 2015 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duane Button, Memorial University of Newfoundland
- Investigators
- Duane Button, PhD, Principal investigator, Memorial University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Pressure Threshold of a Muscle Tender Spot Increases Following Local and Non-local Rolling Massage
- ClinicalTrials.gov ID
- NCT02528812
- Acronym / sponsor ID
- 20140537-HK
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ipsi-R | Experimental | Device: TheraBand Roller MassagerIntervention 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) |
| Contra-R | Experimental | Device: TheraBand Roller MassagerIntervention group 2 included participants receiving heavy roller massage via the TheraBand Roller Massager on the calf of the contralateral limb (Contralateral Rolling: Contra-R) |
| Sham group | Sham comparator | Device: TheraBand Roller MassagerThe sham group received light stroking of the skin with TheraBand roller massager on the calf that exhibited the higher tenderness |
| Ipsi-M | Experimental | Other: Manual MassageIntervention group 3 included participants receiving manual massage on the calf that exhibited the higher tenderness (Ipsilateral Manual: Ipsi-M) |
| control group | No intervention | –received no intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- participants had to exhibit point tenderness in their plantar flexor muscles (gastrocnemius or soleus) either in the left or right limb.
Key exclusion criteria (1 listed)
- having musculoskeletal or visceral chronic pain and taking pain relief medications within the past 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraBand Roller MassagerThe 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. | Device | Contra-R, Ipsi-R, Sham group |
| Manual MassageA massage therapist massaged the participant | Other | Ipsi-M |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 26416265Aboodarda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duane Button, PhD principal investigator
Memorial University
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.