The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy

Diabetic Neuropathy, Painful Clinical Trial

Official title:

The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05670600
• Other study ID #: Gaziüniversite
• Status: Completed
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: September 13, 2021

Study information

• Verified date: January 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be carried out to determine the effect on pain and quality of life between the groups that received and did not receive foot and ankle exercise training.

Description:

In the literature, in patients with diabetic neuropathy who received foot and ankle exercise training; It is observed that it reduces the level of pain and increases the quality of life. Foot and ankle exercise training given to the participants improved blood circulation, improved foot-ankle range of motion, increased foot muscle strength and function, improved diabetic neuropathy symptoms, redistributed plantar pressure during movement, improved sensitivity, and was effective in maintaining balance; It is thought that participants can reduce pain and improve their quality of life with foot and ankle exercise training. While there are studies examining the effect of non-pharmacological interventions such as spa treatment and pulse electromagnetic field therapy in patients with diabetic neuropathy in our country, no study has been found examining the effect of foot and ankle exercise training on pain and quality of life in patients with diabetic neuropathic pain. It is thought that the results of the research will be beneficial in symptom management and improve quality of life in addition to pharmacological treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 13, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and over,
• Having been diagnosed with Type 2 diabetes for at least one year,
• Diagnosed with diabetic peripheral neuropathy for at least 6 months by EMG by a neurologist,
• Individuals with diabetes mellitus with neuropathic pain who score 12 or higher on the S-Lanns (Self-Leeds Assessment of Neuropathic Symptoms and Sign) pain scale,
• Visual Analogue Scale (VAS) value to be at least 1,
• Receiving medical treatment for diabetic neuropathy,
• Did not receive physical therapy and non-pharmacological treatment during the research period,
• Having no physical and mental problems that will prevent communication,
• Having blood glucose meters at home,
• Individuals with smart device use,

Exclusion Criteria:

• Peripheral vascular complications due to diabetes or another etiology,
• Having a history of surgery on the knee, ankle and hip and indication for surgery during the intervention period,
• Those who cannot communicate on the phone (with hearing problems),
• Having nephropathy, retinopathy and diabetic foot,
• Neurological diseases (stroke, cerebrovascular diseases, epilepsy) and serious musculoskeletal problems (rheumatoid arthritis, osteoarthritis)
• Neurocognitive disorder (Alzheimer's disease, dementia),
• Not taking any physical therapy during the intervention period,
• Patients with deep vein thrombosis, femur fractures, surgical conditions, open wounds

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy, Painful

Intervention

Other:
• foot and ankle exercise
Foot and Ankle Exercise Phase Pulling the foot upwards from the ankle Bending the foot down from the ankle Spreading the feet like a fan, moving the toes in and out to the right and left Circle drawing exercise with ankle Towel folding exercise Bottle rolling exercise under the feet (The water in the bottle will be warm tap water)

Locations

Country	Name	City	State
Turkey	Toros Devlet Hastanesi	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (20)

Ahn S, Song R. Effects of Tai Chi Exercise on glucose control, neuropathy scores, balance, and quality of life in patients with type 2 diabetes and neuropathy. J Altern Complement Med. 2012 Dec;18(12):1172-8. doi: 10.1089/acm.2011.0690. Epub 2012 Sep 17. — View Citation

Boyle J, Eriksson ME, Gribble L, Gouni R, Johnsen S, Coppini DV, Kerr D. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes Care. 2012 Dec;35(12):2451-8. doi: 10.2337/dc12-0656. Epub 2012 Sep 18. — View Citation

Cerrahoglu L, Kosan U, Sirin TC, Ulusoy A. Range of Motion and Plantar Pressure Evaluation for the Effects of Self-Care Foot Exercises on Diabetic Patients with and Without Neuropathy. J Am Podiatr Med Assoc. 2016 May;106(3):189-200. doi: 10.7547/14-095. — View Citation

Chang CF, Chang CC, Hwang SL, Chen MY. Effects of Buerger Exercise Combined Health-Promoting Program on Peripheral Neurovasculopathy Among Community Residents at High Risk for Diabetic Foot Ulceration. Worldviews Evid Based Nurs. 2015 Jun;12(3):145-53. do — View Citation

Degu H, Wondimagegnehu A, Yifru YM, Belachew A. Is health related quality of life influenced by diabetic neuropathic pain among type II diabetes mellitus patients in Ethiopia? PLoS One. 2019 Feb 4;14(2):e0211449. doi: 10.1371/journal.pone.0211449. eCollection 2019. — View Citation

Dermanovic Dobrota V, Hrabac P, Skegro D, Smiljanic R, Dobrota S, Prkacin I, Brkljacic N, Peros K, Tomic M, Lukinovic-Skudar V, Basic Kes V. The impact of neuropathic pain and other comorbidities on the quality of life in patients with diabetes. Health Qual Life Outcomes. 2014 Dec 3;12:171. doi: 10.1186/s12955-014-0171-7. — View Citation

Feldman EL, Callaghan BC, Pop-Busui R, Zochodne DW, Wright DE, Bennett DL, Bril V, Russell JW, Viswanathan V. Diabetic neuropathy. Nat Rev Dis Primers. 2019 Jun 13;5(1):41. doi: 10.1038/s41572-019-0092-1. — View Citation

Francia P, Anichini R, De Bellis A, Seghieri G, Lazzeri R, Paternostro F, Gulisano M. Diabetic foot prevention: the role of exercise therapy in the treatment of limited joint mobility, muscle weakness and reduced gait speed. Ital J Anat Embryol. 2015;120(1):21-32. — View Citation

Hazari A, Maiya AG, Shivashankara KN, Agouris I, Monteiro A, Jadhav R, Kumar S, Shashi Kumar CG, Mayya SS. Kinetics and kinematics of diabetic foot in type 2 diabetes mellitus with and without peripheral neuropathy: a systematic review and meta-analysis. Springerplus. 2016 Oct 19;5(1):1819. doi: 10.1186/s40064-016-3405-9. eCollection 2016. — View Citation

Kanchanasamut W, Pensri P. Effects of weight-bearing exercise on a mini-trampoline on foot mobility, plantar pressure and sensation of diabetic neuropathic feet; a preliminary study. Diabet Foot Ankle. 2017 Feb 20;8(1):1287239. doi: 10.1080/2000625X.2017. — View Citation

Kluding PM, Pasnoor M, Singh R, Jernigan S, Farmer K, Rucker J, Sharma NK, Wright DE. The effect of exercise on neuropathic symptoms, nerve function, and cutaneous innervation in people with diabetic peripheral neuropathy. J Diabetes Complications. 2012 S — View Citation

Monteiro RL, Ferreira JSSP, Silva EQ, Donini A, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diab — View Citation

Monteiro RL, Sartor CD, Ferreira JSSP, Dantas MGB, Bus SA, Sacco ICN. Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a — View Citation

Mueller MJ, Tuttle LJ, Lemaster JW, Strube MJ, McGill JB, Hastings MK, Sinacore DR. Weight-bearing versus nonweight-bearing exercise for persons with diabetes and peripheral neuropathy: a randomized controlled trial. Arch Phys Med Rehabil. 2013 May;94(5):829-38. doi: 10.1016/j.apmr.2012.12.015. Epub 2012 Dec 28. — View Citation

Sacco IC, Picon AP, Macedo DO, Butugan MK, Watari R, Sartor CD. Alterations in the lower limb joint moments precede the peripheral neuropathy diagnosis in diabetes patients. Diabetes Technol Ther. 2015 Jun;17(6):405-12. doi: 10.1089/dia.2014.0284. Epub 20 — View Citation

Sartor CD, Hasue RH, Cacciari LP, Butugan MK, Watari R, Passaro AC, Giacomozzi C, Sacco IC. Effects of strengthening, stretching and functional training on foot function in patients with diabetic neuropathy: results of a randomized controlled trial. BMC M — View Citation

Sartor CD, Watari R, Passaro AC, Picon AP, Hasue RH, Sacco IC. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. — View Citation

van Laake-Geelen CCM, Smeets RJEM, Quadflieg SPAB, Kleijnen J, Verbunt JA. The effect of exercise therapy combined with psychological therapy on physical activity and quality of life in patients with painful diabetic neuropathy: a systematic review. Scand J Pain. 2019 Jul 26;19(3):433-439. doi: 10.1515/sjpain-2019-0001. — View Citation

van Schie CH. Neuropathy: mobility and quality of life. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S45-51. doi: 10.1002/dmrr.856. — View Citation

Win MMTM, Fukai K, Nyunt HH, Linn KZ. Hand and foot exercises for diabetic peripheral neuropathy: A randomized controlled trial. Nurs Health Sci. 2020 Jun;22(2):416-426. doi: 10.1111/nhs.12676. Epub 2019 Dec 26. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain level at 4th and 8th weeks compared to baseline.	Pain scores of the patients were checked after foot and ankle exercise training. The scale, developed by Price, McGrath, Rafii, and Buckingham, is a measurement tool that evaluates pain severity. The scale is 10 cm long and is graded on a horizontal line (0 = no pain, 10 = most severe pain). The patient is asked to mark a point on this line that corresponds to the intensity of pain he feels. The marked numerical value indicates the severity of the patient's perception of pain. A VAS value of 1 to 4 indicates mild pain, 5-6 indicates moderate pain, and 7-10 indicates severe pain. As scores increase, the level of pain worsens and general health deteriorates.	Two months
Secondary	Effect of neuropathic pain on quality of life at 4 and 8 weeks change from initial state	After the interventions, the patient's scores on the effect of neuropathic pain on quality of life are checked. Poole, Murphy, and Nurmka (2009) developed a questionnaire on the impact of neuropathic pain on quality of life. The scale consisting of 42 items; symptoms were divided into 6 subscales under the headings of relationships, psychological, social activity, physical activity, and personal/self care. The results of the questionnaire on the effect of neuropathic pain on the quality of life were calculated by summing the 42-item scores. The total score range is between 42 and 210. The score range for each item is between 1 and 5.	Two months