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Lower Limb AmputationNCT04285138

Phantom Exercise for Lower Limb Amputees

A study testing phantom limb exercise and conventional treatment in people with Lower Limb Amputation, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this research, the aim is to find out the effects of phantom exercises in terms of pain, mobility and quality of life among lower-limb amputees having phantom limb pain. This is a randomized control trial in which amputees having phantom limb pain will be randomly divided into two groups i.e. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Lower Limb Amputation
What is being tested?
phantom limb exercise and conventional treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 sitePakistan
Study dates
1 Jul 2020to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Unilateral lower limb amputation
  • Phantom limb pain score (40-100 on VAS)
  • Either gender
  • Stable prosthetic situation (i.e. satisfaction with the fitting of the prosthesis) or being a non-user.

Who cannot join

  • Amputees with psychological/neurological impairments.
  • Amputees having neuropathic pain other than phantom limb pain.
  • Patients having visual-spatial impairments.
  • Taking pain relief medications will also be excluded.
  • Patients having residual limb pain.
  • Inability to give informed consent.
Show all 11Show fewer
  • Carcinoma
  • Infectious stump
  • Severe hearing loss
  • Any condition that restricts the movement of opposite limb, pain or limited range of motion in the intact limb
  • Infectious and systematic diseases

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effects of Phantom Exercises on Pain, Mobility and Quality of Life Among Lower Limb Amputees

In this research, the aim is to find out the effects of phantom exercises in terms of pain, mobility and quality of life among lower-limb amputees having phantom limb pain. This is a randomized control trial in which amputees having phantom limb pain will be randomly divided into two groups i.e. Experimental group (Routine physical therapy, mirror therapy and phantom exercises) and control group (Routine physical therapy and mirror therapy). Non-probability purposive sampling technique will be employed. Patients of age between 18 to 50 years and having phantom limb pain after lower limb amputation will be recruited by evaluating with limb deficiency and phantom limb questionnaire. Other tools will be Visual analogue scale (pain), Amputee mobility predictor (Ambulatory status) and 36-Item Short-Form Health Survey questionnaire (Health-related quality of life). The study will be conducted in 6 months and data obtained will be analyzed through Statistical Package for Social Sciences (SPSS) 20.

Read the detailed description

An amputation is a distressing event that will result in physical, psychological, and social consequences. The loss of limb means a huge impact, not only for the patient's body and the way he notices it, as well as the perception of the environment around him. Most of the patients with lower extremity amputations experienced phantom limb pain. It is defined by painful sensation in the missing limb. According to a recent study, the prevalence of phantom limb pain ranges from 45% to 85%. Regardless of the reason for amputation, phantom limb pain diminishes over time in most cases. However, in about 5-10% of amputees' severe pain persists for several years. It affects the patient's capacity for self-care and personal independence as it is mentally and physically debilitating. Incidence of PLP in recent studies is reported to be approximately 42.2-78.8% of amputees. It should be noted that phantom limb pain (PLP) differs from pain in the stump called residual limb pain (RLP), which is due to skin complications, vascular compromise, inappropriate healing, painful neuromas, excess soft tissue and bone irregularities.

However, the exact mechanism of phantom limb pain is unknown, but advancement in pain physiology indicates that multiple mechanisms are involved including peripheral, spinal and supraspinal mechanisms. The first changes may take place in the periphery where the nerve endings are sensitized by pre-amputation pain and nerve transection. But the complexity of phantom phenomena and the association between catastrophizing and phantom limb pain indicate that supraspinal changes play a significant role in phantom pain. It is likely that the relative contributions of these mechanisms vary from one amputee to another and that they may change over time in the individual patient.

It has been seen that phantom limb pain is typically experienced in regions with large cortical representation, such as the hands/fingers and feet/toes. The pain is often described with words such as knifelike, sticking, pricking, shooting, and burning. Both PLP and RLP have a high incidence among amputees. These pains are a continual reminder of circumstances and can affect important factors of Quality of life such as sleep, fatigue mood and relationships compromising the acquisition of skills and quality of life. Thus, interfering with the physical and psychosocial rehabilitation of the amputee. This should be considered clinically during therapeutic encounters, and amputees should be given appropriate information on these potential associations, though often neglected by the medical team. Although QOL in amputees seems primarily determined by mobility impairment, pain, emotional perturbation, it is seen that physician-controlled factors such as the timing of amputation, informed decision making, and postamputation support may also play an important role. This data can be efficiently collected through limb deficiency and phantom limb questionnaire. During the rehabilitation process, multiple tools are available that help physicians to determine both motor ability and mobility in amputees as well as other determinants of quality of life and pain status of amputees. These include tests that determine motor ability as Single-limb standing balance test (Balance test), the Lower-Extremity Motor Coordination Test (LEMOCOT) and the Amputee Mobility Predictor without a prosthesis (AMPnoPRO). The AMP is a highly reliable instrument and it is relatively easy to administer in 15 minutes or less. Patients characteristics can be easily evaluated using "Limb Deficiency and Phantom Limb Questionnaire (Questionnaire 2008, Version 2)" and visual analogue scale (VAS) for the presence and extent of PLP. Health-related quality of life (HRQL) will be measured by the SF-36 questionnaire.

Despite a growing body of evidence, phantom limb pain remains a challenging condition to treat. There remains a large potential for innovation in improving the treatment strategies for these patients. More than 25 treatments for PLP are currently available yet not one is widely accepted or superior to others. Common self-treatment strategies can include wearing an elastic stump sock to minimise volume changes in the residual limb, stump massage, mental imagery of the phantom limb and taking physical exercise.

A rehabilitation technique that proved promising in recent years is mirror therapy, which involves a mirror being placed in a position that allows the patient to view a reflection of a body part. whilst the nonpainful limb is placed in front of the mirror so that it creates a reflection that can be seen by the patient, the stump is kept behind the mirror. In amputees, this creates the illusion of having two intact limbs and then the patient is asked to move an intact limb in certain patterns. This gives the illusion that the painful limb can move normally too. The mechanism of action of mirror therapy remains uncertain, with the reintegration of motor and sensory systems, restored body image and control over fear-avoidance likely to influence the outcome. Nevertheless, mirror therapy is inexpensive, safe and easy for the patient to self-administer but the level of evidence is insufficient. A limitation of the mirror box technique is the poor verisimilitude of the sensory feedback provided from the missing limb. The participant may have the visual illusion that the phantom extremity is moving, but the apparatus is crude and the illusion often not compelling. Patients cannot independently control the mirrored extremity, so only symmetric actions can be modelled.

Moreover, a relatively less researched method of reduction of phantom limb pain is Phantom exercises (PE). This involved imagining moving the phantom limb and then attempting to perform a few movements. The neurophysiological network activated during phantom limb movements is similar to that of executed movements of intact limbs and differs from the phantom limb imagination network. The dual ability of amputees to execute and imagine movements of their phantom limb and the fact that these two tasks activate distinct cortical networks are important factors to consider when designing rehabilitation programmes for the treatment of phantom limb pain. Few studies indicate that phantom exercises can be used safely to alleviate phantom limb pain in lower and upper limb amputees.

The evidence for clinical efficacy of mirror therapy is encouraging, but not yet definitive. Virtual reality could be a substitute for mirror therapy especially in the case if person suffers from bilateral amputation but even though the use of an immersive virtual reality (VR) environment may have a short-term effect on PLP for the majority of amputees who experience PLP, it's cost remain a problem in developing country like Pakistan, Moreover, because of high prevalence and high pain intensity of phantom limb pain, there is need to find an effective, easily administered home-based treatment for amputees, thus comparing effects of mirror therapy with and without phantom exercises in reducing pain and improving QOL and psychological status of amputees is a useful guide for future studies as these protocols are cost-effective and efficient.

In a pilot, study authors investigated the effects of phantom limb exercises on phantom limb pain. A total of 20 traumatic amputees participated in the study. Ten received phantom exercises and prosthetic training, and 10 were treated with routine prosthetic training and a general exercise programme. They found that pain intensity decreased in all subjects after 4 weeks of treatment in both groups. according to the visual analogue scale scores at the end of 4 weeks, the phantom exercises group differed significantly from the general exercise group. Thus, the study indicated that phantom exercises can be used safely to alleviate phantom limb pain in lower and upper limb amputees.

This study combines the effect of mirror therapy with phantom exercises in the experimental group. Similarly, another randomized controlled trial (RCT) was done to evaluate the reduction in phantom pain and sensation with combined training of progressive muscle relaxation, mental imagery and phantom exercises. This randomized controlled prospective trial with two parallel groups included Fifty-one subjects with unilateral lower limb amputation with Phantom Limb Pain. The experimental group performed combined training of progressive muscle relaxation, mental imagery and phantom exercises 2 times a week for 4 weeks, while the control group had the same amount of physical therapy dedicated to the residual limb. The results showed a significant decrement over time in all the Patient evaluation questionnaire domains (both in terms of phantom limb sensation (PLS) and phantom limb pain (PLP) and Brief pain intensity in experimental groups. The conclusion of this suggested that combined training of progressive muscle relaxation, mental imagery and modified phantom exercises should be taken into account as a valuable technique to reduce phantom limb pain and sensation. As Mirror therapy (MT) has been proposed as an effective rehabilitative strategy to alleviate pain symptoms in amputees with phantom limb pain (PLP) so in this study mirror therapy is used as conventional treatment along with the general exercise programme for amputees.

Being tested
phantom limb exercise, conventional treatment
Keywords
Phantom, Amputation, Prosthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • phantom limb exerciseOther

    phantom limb exercises (that is, active imaginal efforts to move the phantom), under the assumption that the neural pathways involved in performing actual movements are activated when using one's imagination to move the phantom extremity

  • conventional treatmentOther

    Mirror therapy uses a flat mirror placed parasagittally in front of the patient's body with the reflective surface toward the sound limb so that the amputee sees the reflection of the sound limb in the mirror [Figure 1]. This reflection mimics the amputated limb, and with the movement of the intact limb, the mirror provides an optical illusion that the phantom limb is moving simultaneously.

    Equipment:

    Therapy mirror: A standing mirror (130 cm × 46 cm) with wooden frame and base (62 cm × 65 cm) Routine physiotherapy The general exercise programme consisted of strengthening, stretching, dynamic, and isometric exercises based on the level of amputation and their assessment results. Participants allocated to the control group were advised to continue rehabilitation at their respective physiotherapy out-patient departments as frequently as possible. Participants were given a diary and advised to record their activities, specifying the nature, frequency and duration of each activity

Study groups in NCT04285138
Study groupRoleWhat they receive
Phantom limb exercisesExperimentalParticipants in this group will be treated with routine physical therapy, mirror therapy and Phantom limb exercises. Treatment time: 1 hour
Receives: Other: phantom limb exercise
conventional treatmentActive comparatorIn this group, participants will be treated by routine physical therapy and mirror therapy protocol. Treatment time: 35 minutes
Receives: Other: conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue scale (VAS)

    changes from the baseline, The visual analogue scale The VAS evaluates pain subjectively. It consists of a 100-mm line, with two endpoints representing "no pain" to "worst pain imaginable from left to right." Patients are instructed to mark on the line according to the level of pain and the same is measured

    Measured: 4 weeks

  2. Amputee Mobility predictor

    changes from the baseline, Amputee mobility predictor (AMP) is an amputee-specific tool for predicting ambulatory potential. This clinical test evaluates the predicted mobility of amputee with and without a prosthesis The AMP is a clinical test consisting of 20 tasks that are given a score of 0, 1, or 2 based on the amputee's performance. There is an item 21 where a score is given ranging from 0 to 5.

    Measured: 4 weeks

  3. Limb Deficiency and Phantom Limb Questionnaire

    Patients will be evaluated using "Limb Deficiency and Phantom Limb Questionnaire (Questionnaire 2008, Version 2)" in order to assess their eligibility for including in this study.

    this questionnaire does not have any scoring, it only concludes the questions on Yes/No basis for presence or absence of phantom limb pain.

    Measured: day 1

Secondary outcomes (1)
  1. Short form 36 (SF-36)

    changes from the baseline, The 36-Item Short-Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of life (HRQOL). It is a widely used valid and reliable tool for measuring the (HRQOL) and it can be employed in both the healthy and diseased population such as amputees for assessing the outcome of health care services and the effect of medical intervention.

    The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2020
  2. Study start1 Jul 2020
  3. Primary completion30 Dec 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phantom exercises involved imagining moving the phantom limb and then attempting to perform these movements The phantom exercises will be administered as follows: (i) subjects will be asked in which position they felt the phantom limb; (ii) they will be asked to place the intact limb in the same position as they felt their phantom limb; (iii) they will be asked to move both limbs in the opposite direction; (iv) they will be then asked to return to the starting position again.
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04285138
Sponsor's protocol ID
REC/Lhr/20/2008 Anna Zaheer
Status last verified
Mar 2021
First submitted
24 Feb 2020
Last updated
30 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Solarz MK, Thoder JJ, Rehman S. Management of Major Traumatic Upper Extremity Amputations. Orthop Clin North Am. 2016 Jan;47(1):127-36. doi: 10.1016/j.ocl.2015.08.013.

    PubMed 26614927
  • Kuffler DP. Coping with Phantom Limb Pain. Mol Neurobiol. 2018 Jan;55(1):70-84. doi: 10.1007/s12035-017-0718-9.

    PubMed 28921418
  • Ayoub SN, Hakim KY. Comparative study of dexmedetomidine or fentanyl as an adjuvant to epidural bupivacaine for prevention of stump and phantom pain in adult patients undergoing above-knee or below-knee amputation: a randomized prospective trial. Research and Opinion in Anesthesia and Intensive Care. 2019;6(3):371

  • Padovani MT, Martins MR, Venancio A, Forni JE. Anxiety, depression and quality of life in individuals with phantom limb pain. Acta Ortop Bras. 2015 Mar-Apr;23(2):107-10. doi: 10.1590/1413-78522015230200990.

    PubMed 27069411
  • Nikolajsen L, Christensen KF. Phantom limb pain. Nerves and Nerve Injuries: Elsevier; 2015. p. 23-34.

  • Hall N, Abd-Elsayed A, Eldabe S. Phantom Limb Pain. Pain: Springer; 2019. p. 907-10.

  • Roberts K. The Role of Positivity: Physical and Mental Aspects of Lower Limb Amputation Due to Diabetes. 2019

  • Trevelyan EG, Turner WA, Robinson N. Perceptions of phantom limb pain in lower limb amputees and its effect on quality of life: a qualitative study. Br J Pain. 2016 May;10(2):70-7. doi: 10.1177/2049463715590884. Epub 2015 Jun 23.

    PubMed 27551416
  • Suckow BD, Goodney PP, Nolan BW, Veeraswamy RK, Gallagher P, Cronenwett JL, Kraiss LW. Domains that Determine Quality of Life in Vascular Amputees. Ann Vasc Surg. 2015;29(4):722-30. doi: 10.1016/j.avsg.2014.12.005. Epub 2015 Feb 26.

    PubMed 25725279
  • Gailey RS, Roach KE, Applegate EB, Cho B, Cunniffe B, Licht S, Maguire M, Nash MS. The amputee mobility predictor: an instrument to assess determinants of the lower-limb amputee's ability to ambulate. Arch Phys Med Rehabil. 2002 May;83(5):613-27. doi: 10.1053/apmr.2002.32309.

    PubMed 11994800
  • Ramadugu S, Nagabushnam SC, Katuwal N, Chatterjee K. Intervention for phantom limb pain: A randomized single crossover study of mirror therapy. Indian J Psychiatry. 2017 Oct-Dec;59(4):457-464. doi: 10.4103/psychiatry.IndianJPsychiatry_259_16.

    PubMed 29497188
  • Pereira ÂM, Ramos A, Rafaela A, João M, Arrifes V. Mobility in patients with lower limb amputation after prosthesis. Annals of Medicine. 2019;51(sup1):212-.

  • Aternali A, Katz J. Recent advances in understanding and managing phantom limb pain. F1000Res. 2019 Jul 23;8:F1000 Faculty Rev-1167. doi: 10.12688/f1000research.19355.1. eCollection 2019.

    PubMed 31354940
  • Le Feuvre P, Aldington D. Know pain know gain: proposing a treatment approach for phantom limb pain. J R Army Med Corps. 2014 Mar;160(1):16-21. doi: 10.1136/jramc-2013-000141. Epub 2013 Jul 31.

    PubMed 24109117
  • Wittkopf PG, Johnson MI. Mirror therapy: A potential intervention for pain management. Rev Assoc Med Bras (1992). 2017 Nov;63(11):1000-1005. doi: 10.1590/1806-9282.63.11.1000.

    PubMed 29451665

Questions about this trial

What is this clinical trial studying?

A study testing phantom limb exercise and conventional treatment in people with Lower Limb Amputation, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue scale (VAS) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04285138, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.

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