Foot and Ankle Mobilisation in Diabetic Peripheral Neuropathy

University of Plymouth

Status: Completed

Conditions: Ankle Joint Range of Motion; Forefoot Peak Plantar Pressure; Home Exercise Programme / Stretches; Limited Joint Mobility Syndrome; Foot and Ankle Mobilisations; Diabetic Peripheral Neuropathy

Treatments: Other: Manual therapy / joint mobilisations

Study type: Interventional

Funder types: Other

Identifiers

NCT03195855

FHHS-228115-VL-026

Details and patient eligibility

About

Diabetes can affect the blood supply to the nerves in the legs. When this occurs a peripheral neuropathy can occur when the nerves carrying sensory information are affected. People with diabetic peripheral neuropathy have a high risk of foot ulceration and amputation which affects function and associated with high NHS and social care costs. People with diabetes can also have reduced movement at joints caused by increased stiffness in connective tissue. Reductions in ankle and big toe movement leads to increases in the pressure over the sole on the front part of the foot (the forefoot) when walking; this is a risk factor for ulceration.

The study will to assess whether ankle and big toe joint mobilisations and home program of stretches in people with diabetic peripheral neuropathy improves joint range of motion and reduces forefoot peak pressures.

Fifty eight people with diabetic peripheral neuropathy and a moderate risk of plantar ulceration will be recruited from a local podiatry clinic. They will be randomly assigned to an intervention (29 people) or control group (29 people). We will control for between-group differences in age using a minimization process. The intervention will consist of a 6 week program of ankle and big toe joint mobilisation by a physiotherapist and home stretches. The control group will consist of usual care including podiatry interventions.

Outcome measures will be taken at baseline, post intervention and at 3 month follow up by an assessor who does not know the group allocation. Primary outcome will be ankle range while walking with secondary outcomes including big toe joint range, forefoot pressure while walking and balance.

Changes over time between the groups will be compared statistically and the relationship between ankle range of motion and peak plantar pressure will be analysed using linear regression.

Enrollment: 61 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type I or II diabetes with a moderate risk of foot ulceration as defined by i. Detection in less than <8/10 sites on the plantar aspect of the foot using a 10 g monofilament ii. Foot deformity defined and graded using a foot deformity score previously developed for people with diabetes (54) (Attached)
• Peripheral Neuropathy- This is defined according to NICE CG19 guidelines. Here, the ability to detect a 10g monofilament (Owen Mumford "neuropen", UK) at 5 sites per foot on the plantar aspect of the toes (1,3 and 5) and metatarsophalangeal joints (1 and 5) is tested. No feeling in less than 8 sites indicates increased risk of foot ulceration (55)
• Ankle joint stiffness: Static, non-weight bearing ankle dorsiflexion will be measured using goniometry (56). Ankle joint stiffness will be defined as 0 or less ankle dorsiflexion (14, 57) due to recent evidence that these patients are more likely to exhibit limited ankle dorsiflexion of <10 degrees during gait (58).
• Hallux joint stiffness (hallux limitus): Hallux dorsiflexion will be measured using goniometry and will be defined as <10 degrees of available dorsiflexion at the hallux during weight bearing (59, 60).
• Able to walk for 10 meters with or without using a walking aid
• Able to attend 6 sessions over a 6 week period
• Age >18 yrs

Exclusion criteria

• Plantar Ulceration: People with a current ulceration will be excluded from the study.
• Rheumatoid arthritis, ankle and 1st MTP osteoarthritis or Dupuytren's contractures as determined from medical notes and participants subjective response.
• Excessive distal lower limb oedema preventing mobilisation rated visually according to criteria (63). People with >+2 pitting oedema in whom it is not possible to palpate the joint line will also be excluded from the study.
• History of lower limb injury in the past three months, or leg fracture/surgery in last year
• Osteoporosis as determined by the medical notes
• Prolonged (>1 yr.) history of steroid use
• Major amputation of lower limb
• Minor foot digits amputation
• Charcot arthropathy - both stages of acute (determined by the clinical signs of unilateral swelling, elevated skin temperature, erythema and joint effusion in the foot or ankle (61)) and chronic.
• Additional neurological or oncological conditions affecting the lower limb

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

61 participants in 2 patient groups

Ankle and big toe mobilisations combined with home stretches

Experimental group

Description:

Intervention group (n=29): This group will undertake talocural and 1st MTP joint mobilisations (x1/week for 6 weeks) and a 6 week home programme of stretching exercises. 1. Mobilisations: In our study, a traction intervention consisting of two, 2-min sets of Maitland grade II joint traction will precede 2-min sets of Maitland grade III mobilisations with one minute rest in between sets. Four sets will be performed for the ankle and two for the MTP. This protocol has been used previously (19, 43). The direction of mobilisation force will be parallel to the treatment plane and perpendicular to the treatment plane during traction (75). 2. Home Program: There will be 3 stretches prescribed (gastrocnemius, soleus and plantar fascia). Participants will be recommended to undertake three consecutive static stretches for 20-30s with a 1 minute rest period (76). Stretches will occur in standing.

Treatment:

Other: Manual therapy / joint mobilisations

Control group of usual care including podiatry

No Intervention group

Description:

Control group (n=29): Usual care including regular monitoring of foot health by podiatrists as indicated by NICE (NG19) guidelines (78). A review of current clinical practice within the podiatry clinic indicates that people with moderate/intermediate risk are reviewed every 3 months. Interventions include nail care, callus debridement and foot care advice. In both groups, interventions delivered by podiatrists in the study period will be determined from the clinic notes.