Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03676530 |
| Other study ID # |
TSS2018 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 11, 2018 |
| Est. completion date |
October 31, 2018 |
Study information
| Verified date |
October 2018 |
| Source |
Brooke Army Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is intended to determine if compression garments effectively reduce pain in the
treatment of tibial stress syndrome (TSS) in the military population. The study will include
diagnoses of shin splints, which is medically known as tibial stress syndrome and medial
tibial stress syndrome, and compare a treatment group using compression garments to a control
group using passive recovery. Both groups will engage in a progressive walk-to-run program.
The outcomes will be measured by comparison in pain scales pre and post treatments. The
ability to perform a two mile run without pain symptoms will be assessed at the conclusion of
the study by participant's self-reported evaluation. The TSS screening questionnaire will be
obtained at each medical encounter to include the initial visit and follow-up visits at the
four and eight week (+/- 3 days) marks. The self-reported 2-mile run evaluation is included
on the TSSS questionnaire.
Description:
The study objective is to determine whether use of compression garments in the treatment of
tibial stress syndrome will reduce pain compared with passive recovery alone.
Specific aims include evaluation of Visual Analog Scale (VAS) when utilizing compression
garments and passive recovery and a self-reported pain free running assessment by the
participant. VAS evaluation will occur at initial encounter, four weeks from treatment
initiation, and then again at eight weeks from treatment start. The follow up time frames
will have a ± three days to allow flexibility of the participant to follow up. The study will
be assessed with a 60 day evaluation period to coincide with previous study time periods as
well as the ability to lessen the possibility of participants lost to follow up that may be
relocated due to military orders. Assessment of functionality, symptomatic criteria, and
determination if further care is required will occur at each visit. A self-reported pain free
running assessment will be collected via questionnaire at the conclusion of the study.
The investigators intend to prove that compression garments will better reduce pain symptoms
in the treatment of tibial stress syndrome (shin splints) compared with passive recovery
alone.
Conduct a prospective randomized control trial with the objective of determining if the
application of compression garments for the symptomatic treatment of tibial stress syndrome
produces improved rates of pain relief and activity tolerance compared to the control of
passive recovery.
Subject population will be gathered from Fort Sam Houston McWethy TMC patients who consist of
active duty trainees for all military branches of service. Male and female participants from
18-45 years of age presenting with leg pain consistent with tibial stress syndrome will be
considered for this study. Age limitation is based on assumed increase in potential
confounders related to previous injury or pre-existing musculoskeletal conditions.
Approximately 42 participants are required based on comparison with previous studies. This
includes a 20 percent addition to account for participants lost to follow-up. Control group
will be treated with passive recovery only.
ADHOC report on international classification of diseases tenth revision, clinical
modification (ICD10) will be obtained for local comparisons of lower extremity diagnoses.
The inclusion criteria consist of:
- Patients of the McWethy TMC
- Able to provide informed consent (of sound mind)
- Acute or acute on chronic musculoskeletal pain of lower extremity
- 18-45 years of age
- Active duty military trainees of all service branches assigned to unit on Ft Sam Houston
- Pain at presentation indicated on Visual Analog Scale (VAS). All scores indicated on the
VAS will be accepted.
The exclusion criteria consist of:
- Patients outside of the McWethy TMC or not assigned to a unit on Ft Sam Houston
- Patient with lower extremity pain not consistent with tibial stress syndrome
- Participants with open wounds of the lower extremity
- Temperature greater than 38˚ Celsius (100.4 Fahrenheit)
- Pain associated with current diseases (neurologic/rheumatologic/cancer)
- Active infection at injury location
- Patients younger than 18 or older than 45 years of age
This research will be a prospective, randomized control trial. Subjects will be randomly
assigned to one of two conditions: use of compression garments (CG) in the treatment group or
passive recovery in the control group. Subjects will be randomized to either the treatment or
the control group through use of an envelope with separate cards indicating either "relative
rest" or "compression garment" on each individual card within the envelope. The envelope will
be maintained by the PI and/or AI associated with this study. The card within the envelope
will be selected by the study participant at the initial visit after the physical examination
has been completed.
Active duty Service members in training status arriving to the McWethy TMC with acute or
acute on chronic shin pain as a chief complaint will be considered for the study. Only those
meeting the inclusion criteria will be invited to take part in this study. Participants
enrolled in the study will be randomized to either control (n=21) or CG (n=21) groups.
Each subject will be placed on a no run or walk profile for 60 days with the caveat of
gradual return to run expected. The graduated walk-to-run progression program will be in
accordance with Lackland Air Force Base Physical Therapy protocols. Subjects randomized to
the passive recovery (control) group will follow two weeks of total lower extremity rest,
excluding normal daily activities, while gradually integrating impact activity tolerance to
running over the remaining six weeks of the study. Subjects randomized to the CG group will
be measured for orthotics in accordance with manufacturer's recommendations and instructed on
the proper wear and use during their initial visit with the provider. CG will be worn at rest
for the initial two weeks following the initial encounter and then with activity between
weeks two and eight ± three days. CG may be used unilaterally or bilaterally depending on the
chief complaint of the subject. The subject will be instructed to continue wear of the CG for
the duration of the recommended treatment timeline unless an individual's pain scale of 0 has
been achieved and maintained throughout the study time period. The participant will continue
wear of the compression garment throughout the day for the first two weeks and then with
activity for the next six weeks. If the participant develops any worsening of lower extremity
symptoms they will be advised to discontinue use and follow up with their primary care
provider. This data will be included into the research.
Each subject who consents to participate in the current study will complete a study-specific
questionnaire to obtain demographic information such as gender, age, and branch of service.
Demographic information will be collected for follow-up access and ensure contact with each
participating member is included. This information will be used for the purpose of follow-up
or research contact only. No PHI will be included in the data analysis or into research
documentation for any other purpose and will not be included in the final documentation or
research findings annotation. Additionally, information regarding number of days per week
each subject runs will be collected. Specifics on their perceived shin pain will be
ascertained that incorporates location, pain with ambulation, pain with running, pain with
sports activity, unilateral or bilateral symptom complaints, and pain at rest.
Furthermore, provider questioning and physical exam will include appearance of foot arch at
standing, roll of foot with ambulation, tenderness on palpation, pain with provocative tests,
pertinent historical evidence, range of motion, and body mass index. The diagnosis of tibial
stress syndrome will rely on clinical examination only. The diagnosis of medial tibial stress
syndrome has been condensed to tibial stress syndrome to ensure that a broader range of
tibial pain is included. Two common sites of exercise-induced tibial pain have been
described, posteromedial and more proximally anterolateral which reflects the posterior and
anterior tibial compartments, respectively.
CG in the treatment of TSS pain is likely to be a simple intervention that utilizes a
patient-centered strategy to elicit both short-term and long-term therapeutic benefits.
Knowledge of the range, individuality, and varied temporal patterns of treatment outcomes can
guide potential patients, clinicians, health care providers, and researchers. An informed
characterization of the treatment process in any intervention is needed to support
appropriate care and optimal results. Performing a nested qualitative study within the
pragmatic clinical trial will provide depth and meaning to the health-related outcome
measures. Each participant will be screened using a satisfaction questionnaire after the
treatment phase to obtain an account of his or her receiving the specific treatment related
to shin splint pain in the McWethy TMC.
The primary outcome measure will be determined by using the visual analog scale (VAS) at rest
and compared to with impact activities such as running. VAS is a unidimensional pain
intensity scale; a 10-cm (100-mm) line on which the subject is asked to place a mark that
corresponds with his or her current pain intensity. The secondary outcomes are, pain
time-response after treatment, performance using subjective activity data collection, and
satisfaction using a binomial (yes/no), and the need for further evaluation after study
completion, which will be obtained during follow up at the four week timeframe or via phone
follow-up if member is unable to schedule a face to face visit.
The primary outcome measure (pain level, assessed using the VAS) will be collected at
baseline, four weeks (+/- 3 days), and eight weeks (+/- 3 days) after the initial encounter.
The secondary outcomes (time-response, performance and functionality, satisfaction) will be
measured at baseline, four weeks post initial encounter (+/- 3 days), and eight weeks (+/- 3
days) post initial encounter. Additional data collected, such as pain at rest and with
activity, and physical examination findings will be obtained during the medical visits and
used into data collection.
