Direct Anterior Total Hip Arthroplasty, Lateral Femoral Cutaneous Nerve Injury, Paresthesia, Total Hip Arthroplasty (THA)
Conditions
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
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.
Interventions
DEVICEPercussive Massage Therapy (Toloco or Hyperice Hypervolt GO 2)
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.
OTHERGentle Manual Massage
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.
Sponsors
Zachary M Ricciardelli
Total Joint Specialists
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Two-arm, 1:1 parallel-group design with active comparator
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oxford Hip Score (OHS) from Baseline to Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forgotten Joint Score-12 (FJS-12) from Baseline to Week 6 and Month 3 | Baseline, Week 6, 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. |
| Change in Numeric Rating Pain Scale (NRPS) Score | Postoperative Day 1, Postoperative Day 14, Week 6, Month 3 | 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. |
| Paresthesia Severity Scale (PSS) | Baseline, Week 6, Month 3, Year 1 | 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. |
| Numbness Body Diagram (Percent Thigh Area Affected) | Baseline, Week 6, Month 3, Year 1 | 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. |
| Anterior Thigh Stiffness (Visual Analog Scale, VAS) | Baseline, Week 6, Month 3, Year 1 | Anterior thigh stiffness measured by a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, with higher values indication worse/more stiffness. |
| PROMIS Sleep Disturbance - Short Form 8a | Baseline, Week 6, Month 3, Year 1 | 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). |
Countries
United States
Outcome results
None listed