Acupuncture for Medial Tibial Stress Syndrome in the Primary Care Setting

NCT03753373 | Completed

• 1 other identifier: FWH20180168H
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators want to investigate whether the KB2 acupuncture protocol is an effective method for decreasing pain and improving physical function in adult subjects with medial tibial stress syndrome. The investigators hypothesize that there will be significant improvement in both the acute and long-term timeframes, with respect to measures of pain and function. The investigators will measure shin pain immediately prior to treatment (baseline), immediately after initial treatment, one-, two-, and four-weeks following treatment, then again at three months post-treatment. Functional status will be evaluated at the above intervals using the Pain Disability Index. The Medial Tibial Stress Syndrome (MTSS) Score is a newly developed scoring system for subject-reported outcomes in evaluating treatment of MTSS, and this will be used to evaluate pain relief and physical functional status at initial treatment (baseline) and again at the four-week follow-up. If at the four-week follow-up no significant improvement is noted, subjects in the non-acupuncture treatment group will be given the option to crossover to another KB2 acupuncture treatment regimen, with follow-up as previously noted.

Conditions

Medial Tibial Stress Syndrome

Keywords

acupuncture; Medial Tibial Stress Syndrome

Outcome Measures

Primary Outcomes (2)

• Change in pain over time as measured by 11-point numerical pain rating score (NPRS-11)

  The NPRS is a validated segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion.

  Visit 1 (Day 1) Beginning, Visit 1 (Day 1) End, Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)

• Change in pain over time as measured by Pain Disability Index (PDI)

  The PDI score is a measure of functional status incorporating the dimensions of family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life support activities. The total of these dimensions provides the PDI score, which has been studied as clinically significant when a decrease of 9 points was observed. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which you would normally be involved have been totally disrupted or prevented by the patient's pain.

  Visit 1 (Day 1) , Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)

Secondary Outcomes (1)

• Change in Medial Tibial Stress Syndrome (MTSS) Score over time

  Visit 1 (Day 1) , Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)

Study Arms (2)

Acupuncture and Home Exercise

EXPERIMENTAL

Acupuncture plus the prescribed home exercise program

Other: Acupuncture; Other: Home Exercise Program

Home Exercise Only

ACTIVE COMPARATOR

The prescribed home exercise program alone

Other: Home Exercise Program

Interventions

Acupuncture OTHER

Acupuncture treatments will be utilizing the KB-2 points with manual manipulation accomplished by vigorously running the acupuncturists thumb nail up and down the handle until a perceived sensation change is noted in the subject's posteromedial tibia. A single, sterile 100mm needle will be inserted into the upper third of the medial tibiofibular ligament, followed by a second needle approximately 2-4 cm below the second needle. The needles will be manipulated as detailed above to achieve the sensation change along the posteromedial tibia. The needles will then be irregularly stimulated over the course of 5-7 minutes. The needles will be removed after the treatment is complete, which will last approximately 5-10 minutes (standard care).

Acupuncture and Home Exercise

Home Exercise Program OTHER

Subjects will be given a study diary to document the number of times they performed the standard of care prescribed home exercise program. Subjects will be advised to complete the stretching exercises daily and the strengthening exercises every other day.

Acupuncture and Home Exercise; Home Exercise Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female DoD beneficiaries, age 18 years or older,
• Diagnosed with medial tibial stress syndrome (in one or both of their lower extremities) OR subjects meeting criteria of pain in the posteromedial tibia with exercise and direct palpation of the posteromedial tibia. Subjects with acute and chronic diagnoses will be included.

You may not qualify if:

• Pregnant
• Any of the following in the lower extremity being included into the study:
• Active cellulitis of lower extremity
• Tibial stress fracture
• If they have ever had any prior acupuncture for medial tibial stress syndrome using the defined KB-2 points.
• Use of anticoagulants
• Neurologic deficits, to include abnormal sensation, hypo- or hyper-active reflexes, muscle weakness not attributable to pain
• History of needle-shock with acupuncture

Sponsors & Collaborators

• Eglin AFB Regional Hospital: lead

Study Sites (1)

96th Medical Group

Eglin Air Force Base, Florida, 32542, United States

Location

Related Publications (5)

• Garnock C, Witchalls J, Newman P. Predicting individual risk for medial tibial stress syndrome in navy recruits. J Sci Med Sport. 2018 Jun;21(6):586-590. doi: 10.1016/j.jsams.2017.10.020. Epub 2017 Oct 23.

  PMID: 29122474 BACKGROUND

• Winters M, Eskes M, Weir A, Moen MH, Backx FJ, Bakker EW. Treatment of medial tibial stress syndrome: a systematic review. Sports Med. 2013 Dec;43(12):1315-33. doi: 10.1007/s40279-013-0087-0.

  PMID: 23979968 BACKGROUND

• Rompe JD, Cacchio A, Furia JP, Maffulli N. Low-energy extracorporeal shock wave therapy as a treatment for medial tibial stress syndrome. Am J Sports Med. 2010 Jan;38(1):125-32. doi: 10.1177/0363546509343804. Epub 2009 Sep 23.

  PMID: 19776340 BACKGROUND

• Reshef N, Guelich DR. Medial tibial stress syndrome. Clin Sports Med. 2012 Apr;31(2):273-90. doi: 10.1016/j.csm.2011.09.008.

  PMID: 22341017 BACKGROUND

• Soer R, Reneman MF, Vroomen PC, Stegeman P, Coppes MH. Responsiveness and minimal clinically important change of the Pain Disability Index in patients with chronic back pain. Spine (Phila Pa 1976). 2012 Apr 15;37(8):711-5. doi: 10.1097/BRS.0b013e31822c8a7a.

  PMID: 21796022 BACKGROUND

MeSH Terms

Conditions

Medial Tibial Stress Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Julie A Creech, DO

  Eglin AFB, United States Air Force

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 27, 2018
• Study Start: January 11, 2019
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

US (1)