Total Joint Specialists
Cumming, Georgia, 30041, United States
NCT Number: NCT07790705
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cumming, Georgia, 30041, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Massage gun therapy, vibration percussion therapy
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Interested in participating?
Request InfoZachary M Ricciardelli
Network
Efficacy of Self-Administered Percussive Massage Therapy Versus Gentle Manual Massage to the Thigh Following Anterior Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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