NCT07790705

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

Anterior Total Hip ArthroplastyDirect Anterior ApproachBikini IncisionLateral Femoral Cutaneous NerveMeralgia ParestheticaPercussive Massage TherapyMassage GunManual MassageNerve NeurapraxiaPostoperative PainThigh Numbness

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (pre-operative) and Week 6 postoperatively

Secondary Outcomes (2)

  • Change in Forgotten Joint Score-12 (FJS-12) from Baseline to Week 6 and Month 3

    Baseline, Week 6, Month 3

  • Change in Numeric Rating Pain Scale (NRPS) Score

    Postoperative Day 1, Postoperative Day 14, Week 6, Month 3

Study Arms (2)

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.

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.

Device: Percussive Massage Therapy (Toloco or Hyperice Hypervolt GO 2)

Interventions

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.

Also known as: Massage gun therapy, vibration percussion therapy
Percussive Massage Therapy (PMT)

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.

Gentle Manual Massage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Total Joint Specialists

Cumming, Georgia, 30041, United States

Location

MeSH Terms

Conditions

ParesthesiaFemoral NeuropathyPain, Postoperative

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesPostoperative ComplicationsPathologic ProcessesPain

Central Study Contacts

Brandon H Naylor, DO

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Full blinding is not feasible, as participants can visually distinguish the percussive device from manual massage. However, comparator participants are not told the specific identity of the intervention arm - only that they are in a comparison group receiving a different type of thigh therapy. Outcome assessors and statisticians may be blinded to group assignment where feasible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm, 1:1 parallel-group design with active comparator
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Brandon Naylor DO

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 27, 2026

Record last verified: 2026-08

Locations