Plantar Fascitis
Conditions
Keywords
acupuncture, plantar fasiosis
Brief summary
The purpose of this study is to determine if the addition of acupuncture to a standard of care prescribed exercise program is more effective at improving pain and function in adult patients with plantar fasciosis.
Detailed description
Investigators are studying whether a specific acupuncture protocol, when added to the standard of care treatment, can improve pain and function in adults with plantar fasciosis. Investigators hypothesize that there will be a significant improvement in both pain and functional outcomes, both acutely and over time, in the experimental group compared to the control group. Investigators will measure foot pain immediately prior to treatment (baseline), immediately after the initial treatment and at 2 weeks, 4 weeks, and 3 months. The Foot Function Index Revised short form will be used during the same intervals to evaluate foot function. At 3 months, patients in the non-acupuncture group will cross-over into the acupuncture group if still experiencing pain.
Interventions
DEVICEAcupunture
acupuncture for plantar fasciosis Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
OTHERStandard of care
standard of care home exercise program
Sponsors
Mike O'Callaghan Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY. Inclusion Criteria: Male and female DoD beneficiaries, age 18 years or older, who have been diagnosed with plantar fasciitis/fasciosis OR Patients meeting criteria of pain in the bottom of the foot/heel with first steps in the morning & tender to palpation over the medial calcaneal tubercle (where the plantar fascia inserts). Those with acute and chronic diagnoses will be included.
Exclusion criteria
* Pregnant * Absence of leg * Active cellulitis of lower extremity * Prior surgery for plantar fasciitis * Steroid injections in the last 12 weeks for plantar fasciitis; if received in last 12 weeks subjects will be offered to be involved in the study after they have completed a 12 week wash out period. * Any regenerative therapy to include proliferation therapy or platelet rich plasma therapy in the last 12 weeks for plantar fasciitis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed a 12 week wash out period. * Botox injections for plantar fasciitis injections in the last 12 weeks for plantar fasciitis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed a 12 week wash out period. * Use of anticoagulants * If they have every had any prior acupuncture for plantar fasciitis using the defined KB-2 points
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NPRS-11 | 90 days | Numeric Pain Rating Scale. 11 point numeric rating on a scale of 0-10 to measure pain intensity. 0 being no pain, 5 being moderate pain, and 10 being worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FFI-R | 90 days | Revised Foot Function Index Short Form. FFI-R measures the impact of foot pathology on function for 5 subscales of: pain (7 questions), stiffness (7 questions), difficulty (11 questions), activity limitation (3 questions), social issues (6 questions). Each question ranges from 1 (no pain/no stiffness/no difficulty/none of the time) to 4 (severe pain/stiffness/difficulty/all of the time). Subscale scores are added up to a total cumulative score. Minimum total score (least pain/stiffness/difficulty) is 34. Maximum total score (most pain/stiffness/difficulty) is 136. |
Countries
United States
Participant flow
Pre-assignment details
94 total subjects. 78 total subjects analyzed. 39 from the initial placebo group were allowed to crossover once their placebo study role was completed.
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed. | 47 |
| Standard of Care The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
Standard of care: standard of care home exercise program | 47 |
| Crossover At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study.
Acupunture: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed. | 0 |
| Total | 94 |
Baseline characteristics
| Characteristic | Standard of Care | Acupuncture | Total | Crossover |
|---|---|---|---|---|
| Age, Customized age | 45 years STANDARD_DEVIATION 12 | 41 years STANDARD_DEVIATION 12 | 43 years STANDARD_DEVIATION 12 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 43 Participants | 84 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| foot injury history foot injury history-no | 15 participants | 11 participants | 26 participants | — |
| foot injury history foot injury history-yes | 32 participants | 36 participants | 68 participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 10 Participants | 22 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 5 Participants | 13 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 27 Participants | 52 Participants | 0 Participants |
| Region of Enrollment United States | 47 participants | 47 participants | 94 participants | — |
| Sex: Female, Male Female | 24 Participants | 25 Participants | 49 Participants | 0 Participants |
| Sex: Female, Male Male | 23 Participants | 22 Participants | 45 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 | 0 / 39 |
| other Total, other adverse events | 4 / 47 | 1 / 47 | 0 / 39 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 | 0 / 39 |
Outcome results
Primary
NPRS-11
Numeric Pain Rating Scale. 11 point numeric rating on a scale of 0-10 to measure pain intensity. 0 being no pain, 5 being moderate pain, and 10 being worst pain.
Time frame: 90 days
Population: Crossover pulls from the standard of care group. There are not 30 additional subjects, merely 30 subjects pulled from standard of care to crossover to acupuncture group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | NPRS-11 | week 6 | 2.5 score on a scale | Standard Deviation 2.2 |
| Acupuncture | NPRS-11 | week 4 | 2.6 score on a scale | Standard Deviation 2.1 |
| Acupuncture | NPRS-11 | week 0 | 3.8 score on a scale | Standard Deviation 2.4 |
| Acupuncture | NPRS-11 | week 2 | 3.1 score on a scale | Standard Deviation 2.3 |
| Acupuncture | NPRS-11 | week 12 | 2.4 score on a scale | Standard Deviation 2.2 |
| Standard of Care | NPRS-11 | week 4 | 3.3 score on a scale | Standard Deviation 2.5 |
| Standard of Care | NPRS-11 | week 0 | 4.3 score on a scale | Standard Deviation 2.8 |
| Standard of Care | NPRS-11 | week 2 | 3.7 score on a scale | Standard Deviation 2.8 |
| Standard of Care | NPRS-11 | week 6 | 3.0 score on a scale | Standard Deviation 2.2 |
| Standard of Care | NPRS-11 | week 12 | 3.4 score on a scale | Standard Deviation 2.8 |
| Crossover | NPRS-11 | week 12 | 2.6 score on a scale | Standard Deviation 2.2 |
| Crossover | NPRS-11 | week 6 | 2.6 score on a scale | Standard Deviation 2.2 |
| Crossover | NPRS-11 | week 0 | 3.7 score on a scale | Standard Deviation 2.7 |
| Crossover | NPRS-11 | week 4 | 2.1 score on a scale | Standard Deviation 2 |
| Crossover | NPRS-11 | week 2 | 3.0 score on a scale | Standard Deviation 2.6 |
Secondary
FFI-R
Revised Foot Function Index Short Form. FFI-R measures the impact of foot pathology on function for 5 subscales of: pain (7 questions), stiffness (7 questions), difficulty (11 questions), activity limitation (3 questions), social issues (6 questions). Each question ranges from 1 (no pain/no stiffness/no difficulty/none of the time) to 4 (severe pain/stiffness/difficulty/all of the time). Subscale scores are added up to a total cumulative score. Minimum total score (least pain/stiffness/difficulty) is 34. Maximum total score (most pain/stiffness/difficulty) is 136.
Time frame: 90 days
Population: Crossover pulls from the standard of care group. There are not 30 additional subjects, merely 30 subjects pulled from standard of care to crossover to acupuncture group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | FFI-R | week 0 | 73 score on a scale | Standard Deviation 14 |
| Acupuncture | FFI-R | week 6 | 56 score on a scale | Standard Deviation 18 |
| Acupuncture | FFI-R | week 4 | 56 score on a scale | Standard Deviation 16 |
| Acupuncture | FFI-R | week 12 | 52 score on a scale | Standard Deviation 18 |
| Acupuncture | FFI-R | week 2 | 61 score on a scale | Standard Deviation 16 |
| Standard of Care | FFI-R | week 12 | 55 score on a scale | Standard Deviation 21 |
| Standard of Care | FFI-R | week 0 | 70 score on a scale | Standard Deviation 22 |
| Standard of Care | FFI-R | week 2 | 64 score on a scale | Standard Deviation 23 |
| Standard of Care | FFI-R | week 4 | 60 score on a scale | Standard Deviation 21 |
| Standard of Care | FFI-R | week 6 | 58 score on a scale | Standard Deviation 21 |
| Crossover | FFI-R | week 2 | 60 score on a scale | Standard Deviation 22 |
| Crossover | FFI-R | week 12 | 56 score on a scale | Standard Deviation 24 |
| Crossover | FFI-R | week 6 | 58 score on a scale | Standard Deviation 23 |
| Crossover | FFI-R | week 0 | 63 score on a scale | Standard Deviation 17 |
| Crossover | FFI-R | week 4 | 55 score on a scale | Standard Deviation 22 |