ParesthesiaNCT07790705
Percussive vs. Gentle Massage for Recovery After Hip Replacement
A study testing Percussive Massage Therapy (Toloco or Hyperice Hypervolt GO 2) and Gentle Manual Massage in people with Paresthesia and Total Hip Arthroplasty (THA), run by Zachary M Ricciardelli at 1 site in United States.
Trial summary
Many people who have hip replacement surgery through a "bikini incision" on the front of the hip (anterior approach) develop numbness, tingling, burning, or tightness in the front and side of the thigh afterward. This happens because a small nerve near the incision can get irritated during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paresthesia, Total Hip Arthroplasty (THA), Direct Anterior Total Hip Arthroplasty
- What is being tested?
- Percussive Massage Therapy (Toloco or Hyperice Hypervolt GO 2) and Gentle Manual Massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older at the time of surgery
- Scheduled for primary unilateral elective anterior total hip arthroplasty for osteoarthritis, avascular necrosis, or inflammatory arthritis
- Sufficient upper extremity strength and hand dexterity to perform either intervention independently, OR a reliable caregiver willing and able to assist with sessions throughout the 6-week period
- Able to provide written informed consent
- Willing and able to perform twice-daily sessions, maintain a daily log, and attend follow-up visits at Week 6 and Month 3
- Body mass index (BMI) less than 40 kg/m²
Who cannot join
- Revision arthroplasty or prior ipsilateral hip surgery
- Pre-existing neurological condition affecting the ipsilateral anterior or lateral thigh, including peripheral neuropathy, lumbar L2-L4 radiculopathy, meralgia paresthetica, or diabetic amyotrophy
- Confirmed or history of deep vein thrombosis or pulmonary embolism
- Active wound infection, breakdown, dehiscence, or open incision at any treatment session timepoint
- Coagulopathy, bleeding disorder, or supratherapeutic anticoagulation at time of enrollment
- Active malignancy involving the hip or ipsilateral femur
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- Concurrent enrollment in another interventional trial
- Significant cognitive impairment precluding safe self-administration or valid patient-reported outcome completion
- Anticipated contralateral total hip arthroplasty within the 3-month follow-up window
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Self-Administered Percussive Massage Therapy Versus Gentle Manual Massage to the Thigh Following Anterior Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
Many people who have hip replacement surgery through a "bikini incision" on the front of the hip (anterior approach) develop numbness, tingling, burning, or tightness in the front and side of the thigh afterward. This happens because a small nerve near the incision can get irritated during surgery. For most patients these symptoms fade over time, but for some they can last for months or longer.
This study is testing whether a simple, at-home self-care routine can help these symptoms improve faster. Patients will be randomly assigned to one of two groups: one group will use a handheld percussive massage device (like a massage gun) on the thigh twice a day, and the other group will do gentle hand massage on the same areas, for the same amount of time, twice a day. Both routines take about 5 minutes and are done every day for 6 weeks after surgery. Neither device use nor massage is applied directly on or near the surgical incision.
The researchers want to find out whether the massage device works better than gentle hand massage for improving hip pain and function, reducing numbness and tingling, and improving sleep and comfort during recovery. Participants will complete short questionnaires and daily logs, with follow-up visits at 6 weeks and 3 months after surgery.
- Conditions
- Paresthesia, Total Hip Arthroplasty (THA), Direct Anterior Total Hip Arthroplasty, Lateral Femoral Cutaneous Nerve Injury
- Being tested
- Percussive Massage Therapy (Toloco or Hyperice Hypervolt GO 2), Gentle Manual Massage
- Keywords
- Anterior Total Hip Arthroplasty, Direct Anterior Approach, Bikini Incision, Lateral Femoral Cutaneous Nerve, Meralgia Paresthetica, Percussive Massage Therapy, Massage Gun, Manual Massage, Nerve Neurapraxia, Postoperative Pain, Thigh Numbness
- Medical subject headings
- Paresthesia, Femoral Neuropathy, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percussive Massage Therapy (Toloco or Hyperice Hypervolt GO 2)Device
Also called Massage gun therapy, vibration percussion therapy
A handheld percussive massage device (30 Hz frequency, medium amplitude, ball-head attachment) is self-applied to the anterior and lateral thigh in slow, overlapping longitudinal strokes, using device weight only with no added downward pressure. Sessions are performed twice daily (morning and evening) for 5 minutes total (2.5 minutes per anatomical zone), beginning postoperative day 1 and continuing through 6 weeks, maintaining a 2-inch exclusion margin from the surgical incision at all times.
Gentle Manual MassageOther
Gentle massage is self-applied to the anterior and lateral thigh using the flat palm and fingers of the hand in slow, overlapping longitudinal strokes, using hand weight only with no added pressure. Sessions are performed twice daily (morning and evening) for 5 minutes total (2.5 minutes per anatomical zone), beginning postoperative day 1 and continuing through 6 weeks, maintaining a 2-inch exclusion margin from the surgical incision at all times.
| Study group | Role | What they receive |
|---|---|---|
| Gentle Manual Massage | Active comparator | Participants self-administer twice-daily gentle flat-palm manual massage to the identical anatomical zones (anterior and lateral thigh) as the PMT arm, using the same treatment zone map, session duration (5 minutes total, 2.5 minutes per zone), frequency, and incision exclusion margin. No device is used - only the flat palm and fingers of the hand. Receives: Other: Gentle Manual Massage |
| Percussive Massage Therapy (PMT) | Experimental | Participants self-administer twice-daily percussive massage therapy to the anterior and lateral thigh beginning postoperative day 1 and continuing through 6 weeks. Each session lasts 5 minutes total (2.5 minutes per zone) using a study-provided percussive massage device with a ball-head attachment at 30 Hz, medium amplitude, applied with device weight only (no added pressure). A 2-inch exclusion zone is maintained around the incision at all times. The device is returned at the Week 6 visit. Receives: Device: Percussive Massage Therapy (Toloco or Hyperice Hypervolt GO 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxford Hip Score (OHS) from Baseline to Week 6
The OHS is a 12-item, hip-specific patient-reported outcome measure assessing pain and function, including pain at rest and with activity, walking distance, and ability to perform activities of daily living. Each item is scored 0-4; total scores range from 0 (worst) to 48 (best), with higher scores indicating better hip function and less pain. Between-group difference at Week 6 will be adjusted for baseline score, sex, and BMI category.
Measured: Baseline (pre-operative) and Week 6 postoperatively
Secondary outcomes (6)
Change in Forgotten Joint Score-12 (FJS-12) from Baseline to Week 6 and Month 3
Joint awareness during daily and recreational activities, measured by the Forgotten Joint Score-12 (FJS-12). Scores are normalized from 0 to 100, with higher scores indicating greater joint unawareness (a better outcome). Compared between the percussive massage therapy (PMT) and manual massage groups.
Measured: Baseline, Week 6, Month 3
Change in Numeric Rating Pain Scale (NRPS) Score
Anterior thigh pain intensity measured by the Numeric Pain Rating Scale (NRPS), an 11-point scale ranging from 0 to 10, with higher scores indicating worse (greater) pain. Compared between the PMT and manual massage groups.
Measured: Postoperative Day 1, Postoperative Day 14, Week 6, Month 3
Paresthesia Severity Scale (PSS)
Anterior thigh paresthesia burden measured by the Paresthesia Severity Scale (PSS), a composite of two 0-10 subscales (severity and frequency of numbness, tingling, and burning), for a total range of 0 to 20. Higher scores indicate worse (greater) paresthesia burden. Compared between the PMT and manual massage groups.
Measured: Baseline, Week 6, Month 3, Year 1
Numbness Body Diagram (Percent Thigh Area Affected)
Distribution and resolution of anterior thigh numbness, mapped on a standardized body diagram and digitized to yield the percent of total anterior thigh surface area affected, ranging from 0% to 100%. Higher percentages indicate worse (more extensive) numbness. Compared between the PMT and manual massage groups.
Measured: Baseline, Week 6, Month 3, Year 1
Anterior Thigh Stiffness (Visual Analog Scale, VAS)
Anterior thigh stiffness measured by a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, with higher values indication worse/more stiffness.
Measured: Baseline, Week 6, Month 3, Year 1
PROMIS Sleep Disturbance - Short Form 8a
Sleep disturbance measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a, an 8-item instrument scored as a T-score (population mean 50, SD 10), with higher scores indicating greater sleep disturbance (a worse outcome).
Measured: Baseline, Week 6, Month 3, Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, 1:1 parallel-group design with active comparator
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zachary M Ricciardelli
- Sponsor type
- Research network
- Collaborators
- Total Joint Specialists
- Responsible party
- Sponsor-investigator, Zachary M Ricciardelli, Total Joint Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790705
- Sponsor's protocol ID
- NSH 1448
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Self-Administered Percussive Massage Therapy Versus Gentle Manual Massage to the Thigh Following Anterior Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07790705
- Acronym / sponsor ID
- NSH 1448
- Conditions
- Paresthesia, Total Hip Arthroplasty (THA), Direct Anterior Total Hip Arthroplasty, Lateral Femoral Cutaneous Nerve Injury
- Keywords
- Anterior Total Hip Arthroplasty, Direct Anterior Approach, Bikini Incision, Lateral Femoral Cutaneous Nerve, Meralgia Paresthetica, Percussive Massage Therapy, Massage Gun, Manual Massage
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Zachary M RicciardelliResearch network
- Collaborators
- Total Joint Specialists
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- 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.
Many people who have hip replacement surgery through a "bikini incision" on the front of the hip (anterior approach) develop numbness, tingling, burning, or tightness in the front and side of the thigh afterward. This happens because a small nerve near the incision can get irritated during surgery. For most patients these symptoms fade over time, but for some they can last for months or longer.
This study is testing whether a simple, at-home self-care routine can help these symptoms improve faster. Patients will be randomly assigned to one of two groups: one group will use a handheld percussive massage device (like a massage gun) on the thigh twice a day, and the other group will do gentle hand massage on the same areas, for the same amount of time, twice a day. Both routines take about 5 minutes and are done every day for 6 weeks after surgery. Neither device use nor massage is applied directly on or near the surgical incision.
The researchers want to find out whether the massage device works better than gentle hand massage for improving hip pain and function, reducing numbness and tingling, and improving sleep and comfort during recovery. Participants will complete short questionnaires and daily logs, with follow-up visits at 6 weeks and 3 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, 1:1 parallel-group design with active comparator
| Arm | Type | Receives |
|---|---|---|
| Gentle Manual Massage | Active comparator | Other: Gentle Manual MassageParticipants self-administer twice-daily gentle flat-palm manual massage to the identical anatomical zones (anterior and lateral thigh) as the PMT arm, using the same treatment zone map, session duration (5 minutes total, 2.5 minutes per zone), frequency, and incision exclusion margin. No device is used - only the flat palm and fingers of the hand. |
| Percussive Massage Therapy (PMT) | Experimental | Device: Percussive Massage Therapy (Toloco or Hyperice Hypervolt GO 2)Participants self-administer twice-daily percussive massage therapy to the anterior and lateral thigh beginning postoperative day 1 and continuing through 6 weeks. Each session lasts 5 minutes total (2.5 minutes per zone) using a study-provided percussive massage device with a ball-head attachment at 30 Hz, medium amplitude, applied with device weight only (no added pressure). A 2-inch exclusion zone is maintained around the incision at all times. The device is returned at the Week 6 visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older at the time of surgery
- Scheduled for primary unilateral elective anterior total hip arthroplasty for osteoarthritis, avascular necrosis, or inflammatory arthritis
- Sufficient upper extremity strength and hand dexterity to perform either intervention independently, OR a reliable caregiver willing and able to assist with sessions throughout the 6-week period
- Able to provide written informed consent
- Willing and able to perform twice-daily sessions, maintain a daily log, and attend follow-up visits at Week 6 and Month 3
Key exclusion criteria (9 listed)
- Revision arthroplasty or prior ipsilateral hip surgery
- Pre-existing neurological condition affecting the ipsilateral anterior or lateral thigh, including peripheral neuropathy, lumbar L2-L4 radiculopathy, meralgia paresthetica, or diabetic amyotrophy
- Confirmed or history of deep vein thrombosis or pulmonary embolism
- Active wound infection, breakdown, dehiscence, or open incision at any treatment session timepoint
- Coagulopathy, bleeding disorder, or supratherapeutic anticoagulation at time of enrollment
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 |
|---|---|---|
| Percussive Massage Therapy (Toloco or Hyperice Hypervolt GO 2)Also: Massage gun therapy, vibration percussion therapyA handheld percussive massage device (30 Hz frequency, medium amplitude, ball-head attachment) is self-applied to the anterior and lateral thigh in slow, overlapping longitudinal strokes, using device weight only with no added downward pressure. Sessions are performed twice daily (morning and evening) for 5 minutes total (2.5 minutes per anatomical zone), beginning postoperative day 1 and continuing through 6 weeks, maintaining a 2-inch exclusion margin from the surgical incision at all times. | Device | Percussive Massage Therapy (PMT) |
| Gentle Manual MassageGentle massage is self-applied to the anterior and lateral thigh using the flat palm and fingers of the hand in slow, overlapping longitudinal strokes, using hand weight only with no added pressure. Sessions are performed twice daily (morning and evening) for 5 minutes total (2.5 minutes per anatomical zone), beginning postoperative day 1 and continuing through 6 weeks, maintaining a 2-inch exclusion margin from the surgical incision at all times. | Other | Gentle Manual Massage |
Primary outcome
Change in Oxford Hip Score (OHS) from Baseline to Week 6
Time frame: Baseline (pre-operative) and Week 6 postoperatively
The OHS is a 12-item, hip-specific patient-reported outcome measure assessing pain and function, including pain at rest and with activity, walking distance, and ability to perform activities of daily living. Each item is scored 0-4; total scores range from 0 (worst) to 48 (best), with higher scores indicating better hip function and less pain. Between-group difference at Week 6 will be adjusted for baseline score, sex, and BMI category.
6 secondary outcomes
Change in Forgotten Joint Score-12 (FJS-12) from Baseline to Week 6 and Month 3
Time frame: Baseline, Week 6, Month 3
Change in Numeric Rating Pain Scale (NRPS) Score
Time frame: Postoperative Day 1, Postoperative Day 14, Week 6, Month 3
Paresthesia Severity Scale (PSS)
Time frame: Baseline, Week 6, Month 3, Year 1
Numbness Body Diagram (Percent Thigh Area Affected)
Time frame: Baseline, Week 6, Month 3, Year 1
Anterior Thigh Stiffness (Visual Analog Scale, VAS)
Time frame: Baseline, Week 6, Month 3, Year 1
PROMIS Sleep Disturbance - Short Form 8a
Time frame: Baseline, Week 6, Month 3, Year 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percussive Massage Therapy (Toloco or Hyperice Hypervolt GO 2) and Gentle Manual Massage in people with Paresthesia and Total Hip Arthroplasty (THA), run by Zachary M Ricciardelli at 1 site in United States.
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 6 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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 Oxford Hip Score (OHS) from Baseline to Week 6 (time frame: Baseline (pre-operative) and Week 6 postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.